Trial Outcomes & Findings for The Effect of Natrox® Oxygen Wound Therapy on the Healing Rate of Chronic Diabetic Foot Ulcers (NCT NCT03905863)

Last Updated: 2021-11-22

Results Overview

Photographic wound evaluation and measurements were conducted utilizing an AI-driven computerized planimetry imaging system (Tissue Analytics, Inc., Baltimore, MD USA).15 This system obtained both 2D and 3D assessments of the wound at each visit through a standardized mobile device; in addition, the lead investigator reviewed all digital images.

Recruitment status

COMPLETED

Study phase

Target enrollment

145 participants

Primary outcome timeframe

Twelve (12) weeks from Time 0

Results posted on

2021-11-22

Participant Flow

Participants were initially screened and documentation was investigated. If all inclusion criteria were met, and the patient had a documented healing rate of \<20% reduction in wound size, the patients were entered into the 2-week run-in period. All patients were allocated to standard of care (SOC). At the baseline visit, if all inclusion and exclusion criteria were still applicable and the wound had not reduced in size by \>20%, the patient was then randomized.

During run-in period patients either exceeded the percentage of acceptable healing per the protocol or had an adverse event preventing continuation in the trial.

Participant milestones

Participant milestones
Measure	Standard of Care Arm SOC was defined to include wound cleansing with sterile water or saline solution, and gentle irrigation of the study ulcer with warm tap water; sharp debridement using a standardized protocol based on TIME principles for wound bed preparation; offloading with a TCC twice in the first week and weekly thereafter (all exceptions had to be agreed by the lead investigator; a fixed ankle walker boot or similar device was acceptable as an alternative, but shoe inserts were not deemed to provide sufficient offloading); moisture balance was provided using a hydrofibre or alginate dressing. In addition, patients were instructed on adherence to the protocol and given instructions to call their clinic if they suspected any signs of an infection.	Intervention Arm Those subjects allocated to the intervention arm were treated using the same protocol as SOC only but were also provided with a Natrox® Oxygen Wound Therapy System, consisting of two elements: the Natrox® Oxygen Generator and the Natrox® Oxygen Delivery System. The oxygen generator is a multi-use battery powered device which generates oxygen though water electrolysis at a rate of 15mL/hr. The oxygen delivery system is a sterile, single use device which has a web-like design that allows wound exudate to pass through to the secondary dressing while allowing the diffusion of oxygen across the wound bed. It connects directly to the oxygen generator via a thin flexible fine-bore tube. While the oxygen delivery device can remain in situ for 7 days, it should be changed at each dressing change, based on exudate level or clinical judgement. This is a battery-operated system with a 30-hour battery life; the kit includes two interchangeable, rechargeable batteries. Each participant was advised to charge one battery while the other was in use, as the battery required changing daily. The oxygen generator is worn in a holster so that patients can remain ambulatory.
Overall Study STARTED	64	81
Overall Study COMPLETED	59	69
Overall Study NOT COMPLETED	5	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard of Care Arm SOC was defined to include wound cleansing with sterile water or saline solution, and gentle irrigation of the study ulcer with warm tap water; sharp debridement using a standardized protocol based on TIME principles for wound bed preparation; offloading with a TCC twice in the first week and weekly thereafter (all exceptions had to be agreed by the lead investigator; a fixed ankle walker boot or similar device was acceptable as an alternative, but shoe inserts were not deemed to provide sufficient offloading); moisture balance was provided using a hydrofibre or alginate dressing. In addition, patients were instructed on adherence to the protocol and given instructions to call their clinic if they suspected any signs of an infection.	Intervention Arm Those subjects allocated to the intervention arm were treated using the same protocol as SOC only but were also provided with a Natrox® Oxygen Wound Therapy System, consisting of two elements: the Natrox® Oxygen Generator and the Natrox® Oxygen Delivery System. The oxygen generator is a multi-use battery powered device which generates oxygen though water electrolysis at a rate of 15mL/hr. The oxygen delivery system is a sterile, single use device which has a web-like design that allows wound exudate to pass through to the secondary dressing while allowing the diffusion of oxygen across the wound bed. It connects directly to the oxygen generator via a thin flexible fine-bore tube. While the oxygen delivery device can remain in situ for 7 days, it should be changed at each dressing change, based on exudate level or clinical judgement. This is a battery-operated system with a 30-hour battery life; the kit includes two interchangeable, rechargeable batteries. Each participant was advised to charge one battery while the other was in use, as the battery required changing daily. The oxygen generator is worn in a holster so that patients can remain ambulatory.
Overall Study Adverse Event	2	4
Overall Study Withdrawal by Subject	2	2
Overall Study Physician Decision	0	3
Overall Study Lost to Follow-up	1	0
Overall Study Protocol Violation	0	2
Overall Study Death	0	1

Baseline Characteristics

One patient did not declare.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care Arm n=64 Participants Patients in the standard of care arm will receive the standard care for their type of wound from their wound care centre.	Intervention Arm n=81 Participants Patients in the intervention arm will receive standard of care plus Natrox® Oxygen Wound Therapy as treatment for their wound. Natrox® Oxygen Wound Therapy: A battery-operated device which delivers 98% pure humidified oxygen to the wound bed through water electrolysis via a sterile oxygen delivery system.	Total n=145 Participants Total of all reporting groups
Age, Continuous	62.69 years n=64 Participants	64.2 years n=81 Participants	63 years n=145 Participants
Sex: Female, Male Female	11 Participants n=64 Participants • One patient did not declare.	26 Participants n=80 Participants • One patient did not declare.	37 Participants n=144 Participants • One patient did not declare.
Sex: Female, Male Male	53 Participants n=64 Participants • One patient did not declare.	54 Participants n=80 Participants • One patient did not declare.	107 Participants n=144 Participants • One patient did not declare.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Puerto Rico	8 participants n=64 Participants	5 participants n=81 Participants	13 participants n=145 Participants
Region of Enrollment United States	56 participants n=64 Participants	76 participants n=81 Participants	132 participants n=145 Participants
Current use Tobacco Yes	11 Participants n=64 Participants	11 Participants n=81 Participants	22 Participants n=145 Participants
Current use Tobacco No	51 Participants n=64 Participants	68 Participants n=81 Participants	119 Participants n=145 Participants
Current use Tobacco Not declared	2 Participants n=64 Participants	2 Participants n=81 Participants	4 Participants n=145 Participants
Diabetes duration	18.33 years n=60 Participants • Analysis was only completed on the 2 individual study arms.	18.35 years n=76 Participants • Analysis was only completed on the 2 individual study arms.	18.34 years n=136 Participants • Analysis was only completed on the 2 individual study arms.
BMI	31 Kg/m^2 n=60 Participants • BMI Analysis: Was only completed on the 2 individual arms.	30.8 Kg/m^2 n=76 Participants • BMI Analysis: Was only completed on the 2 individual arms.	30.9 Kg/m^2 n=136 Participants • BMI Analysis: Was only completed on the 2 individual arms.

PRIMARY outcome

Timeframe: Twelve (12) weeks from Time 0

Population: Intention to treat

Outcome measures

Outcome measures
Measure	Standard of Care Arm n=64 Participants SOC was defined to include wound cleansing with sterile water or saline solution, and gentle irrigation of the study ulcer with warm tap water; sharp debridement using a standardized protocol based on TIME principles for wound bed preparation; offloading with a TCC twice in the first week and weekly thereafter (all exceptions had to be agreed by the lead investigator; a fixed ankle walker boot or similar device was acceptable as an alternative, but shoe inserts were not deemed to provide sufficient offloading); moisture balance was provided using a hydrofibre or alginate dressing. In addition, patients were instructed on adherence to the protocol and given instructions to call their clinic if they suspected any signs of an infection.	Intervention Arm n=81 Participants Those subjects allocated to the intervention arm were treated using the same protocol as SOC only but were also provided with a Natrox® Oxygen Wound Therapy System, consisting of two elements: the Natrox® Oxygen Generator and the Natrox® Oxygen Delivery System. The oxygen generator is a multi-use battery powered device which generates oxygen though water electrolysis at a rate of 15mL/hr. The oxygen delivery system is a sterile, single use device which has a web-like design that allows wound exudate to pass through to the secondary dressing while allowing the diffusion of oxygen across the wound bed. It connects directly to the oxygen generator via a thin flexible fine-bore tube. While the oxygen delivery device can remain in situ for 7 days, it should be changed at each dressing change, based on exudate level or clinical judgement. This is a battery-operated system with a 30-hour battery life; the kit includes two interchangeable, rechargeable batteries. Each participant was advised to charge one battery while the other was in use, as the battery required changing daily. The oxygen generator is worn in a holster so that patients can remain ambulatory.
Number of Participants That Achieve Complete Wound Closure During the Twelve Week Study and the Percentage Change in Participant Ulcer Size at 12 Weeks From Baseline. Intention to treat-healed	18 Participants	36 Participants
Number of Participants That Achieve Complete Wound Closure During the Twelve Week Study and the Percentage Change in Participant Ulcer Size at 12 Weeks From Baseline. Per protocol-healed	18 Participants	36 Participants

PRIMARY outcome

Timeframe: Twelve (12) weeks from Time 0

Population: "Intention to treat" as well an "Per protocol" analysis was carried out.

Wound size change over time using a wound imaging measurement system. Percentage change in ulcer area was calculated on the basis of area change from the start of the study to the final recorded value. Any healed ulcer was recorded as having achieved 100% reduction in area; positive values indicate a reduction in size over the 12-week period while negative values indicate that the ulcer increased in size.

Outcome measures

Outcome measures
Measure	Standard of Care Arm n=64 Participants SOC was defined to include wound cleansing with sterile water or saline solution, and gentle irrigation of the study ulcer with warm tap water; sharp debridement using a standardized protocol based on TIME principles for wound bed preparation; offloading with a TCC twice in the first week and weekly thereafter (all exceptions had to be agreed by the lead investigator; a fixed ankle walker boot or similar device was acceptable as an alternative, but shoe inserts were not deemed to provide sufficient offloading); moisture balance was provided using a hydrofibre or alginate dressing. In addition, patients were instructed on adherence to the protocol and given instructions to call their clinic if they suspected any signs of an infection.	Intervention Arm n=81 Participants Those subjects allocated to the intervention arm were treated using the same protocol as SOC only but were also provided with a Natrox® Oxygen Wound Therapy System, consisting of two elements: the Natrox® Oxygen Generator and the Natrox® Oxygen Delivery System. The oxygen generator is a multi-use battery powered device which generates oxygen though water electrolysis at a rate of 15mL/hr. The oxygen delivery system is a sterile, single use device which has a web-like design that allows wound exudate to pass through to the secondary dressing while allowing the diffusion of oxygen across the wound bed. It connects directly to the oxygen generator via a thin flexible fine-bore tube. While the oxygen delivery device can remain in situ for 7 days, it should be changed at each dressing change, based on exudate level or clinical judgement. This is a battery-operated system with a 30-hour battery life; the kit includes two interchangeable, rechargeable batteries. Each participant was advised to charge one battery while the other was in use, as the battery required changing daily. The oxygen generator is worn in a holster so that patients can remain ambulatory.
Percentage Reduction in Ulcer Area (cm^2). Intention to treat - percentage reduction	41.05 Percentage reduction Standard Deviation 69.82	46.38 Percentage reduction Standard Deviation 100.24
Percentage Reduction in Ulcer Area (cm^2). Per protocol-percentage reduction	40.44 Percentage reduction Standard Deviation 72.1	70.18 Percentage reduction Standard Deviation 45.5

SECONDARY outcome

Timeframe: Up to twelve (12) weeks from Time 0

Population: VAS scores were taken weekly. On a scale of 0-10, 0 is least pain and 10 is the most pain

Does pain associated with the wound change over time using a Visual Analogue Scale Pain intensity of the reference DFU is to be assessed before any dressing changes or other ulcer manipulations at all screening and treatment visits. Subject will be asked to indicate a numerical value that best represents the pain intensity at ulcer site on a scale of 0 to 10 anchored by word descriptors at each end, as "no pain" on the left side and "worst possible pain" on the right side of the number line. The number 0 represent "no pain", the number 5 represents "moderate pain" and the number 10 represents the "worst possible pain". The subject indicates the level of pain intensity by selecting a number on the line that represents their perception of their current state.

Outcome measures

Outcome measures
Measure	Standard of Care Arm n=64 Participants SOC was defined to include wound cleansing with sterile water or saline solution, and gentle irrigation of the study ulcer with warm tap water; sharp debridement using a standardized protocol based on TIME principles for wound bed preparation; offloading with a TCC twice in the first week and weekly thereafter (all exceptions had to be agreed by the lead investigator; a fixed ankle walker boot or similar device was acceptable as an alternative, but shoe inserts were not deemed to provide sufficient offloading); moisture balance was provided using a hydrofibre or alginate dressing. In addition, patients were instructed on adherence to the protocol and given instructions to call their clinic if they suspected any signs of an infection.	Intervention Arm n=81 Participants Those subjects allocated to the intervention arm were treated using the same protocol as SOC only but were also provided with a Natrox® Oxygen Wound Therapy System, consisting of two elements: the Natrox® Oxygen Generator and the Natrox® Oxygen Delivery System. The oxygen generator is a multi-use battery powered device which generates oxygen though water electrolysis at a rate of 15mL/hr. The oxygen delivery system is a sterile, single use device which has a web-like design that allows wound exudate to pass through to the secondary dressing while allowing the diffusion of oxygen across the wound bed. It connects directly to the oxygen generator via a thin flexible fine-bore tube. While the oxygen delivery device can remain in situ for 7 days, it should be changed at each dressing change, based on exudate level or clinical judgement. This is a battery-operated system with a 30-hour battery life; the kit includes two interchangeable, rechargeable batteries. Each participant was advised to charge one battery while the other was in use, as the battery required changing daily. The oxygen generator is worn in a holster so that patients can remain ambulatory.
Level of Pain of the Wound Baseline	2.02 score on a VAS 0-10 scale Standard Deviation 2.57	1.81 score on a VAS 0-10 scale Standard Deviation 2.53
Level of Pain of the Wound Twelve weeks of final visit if healed during study	0.68 score on a VAS 0-10 scale Standard Deviation 1.43	0.95 score on a VAS 0-10 scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Up to twelve (12) weeks from time 0

Population: Adverse reactions were recorded and reported throughout the study as they occurred.

Number of adverse events, such as infections, that are found associated with the study wound

Outcome measures

Outcome measures
Measure	Standard of Care Arm n=64 Participants SOC was defined to include wound cleansing with sterile water or saline solution, and gentle irrigation of the study ulcer with warm tap water; sharp debridement using a standardized protocol based on TIME principles for wound bed preparation; offloading with a TCC twice in the first week and weekly thereafter (all exceptions had to be agreed by the lead investigator; a fixed ankle walker boot or similar device was acceptable as an alternative, but shoe inserts were not deemed to provide sufficient offloading); moisture balance was provided using a hydrofibre or alginate dressing. In addition, patients were instructed on adherence to the protocol and given instructions to call their clinic if they suspected any signs of an infection.	Intervention Arm n=81 Participants Those subjects allocated to the intervention arm were treated using the same protocol as SOC only but were also provided with a Natrox® Oxygen Wound Therapy System, consisting of two elements: the Natrox® Oxygen Generator and the Natrox® Oxygen Delivery System. The oxygen generator is a multi-use battery powered device which generates oxygen though water electrolysis at a rate of 15mL/hr. The oxygen delivery system is a sterile, single use device which has a web-like design that allows wound exudate to pass through to the secondary dressing while allowing the diffusion of oxygen across the wound bed. It connects directly to the oxygen generator via a thin flexible fine-bore tube. While the oxygen delivery device can remain in situ for 7 days, it should be changed at each dressing change, based on exudate level or clinical judgement. This is a battery-operated system with a 30-hour battery life; the kit includes two interchangeable, rechargeable batteries. Each participant was advised to charge one battery while the other was in use, as the battery required changing daily. The oxygen generator is worn in a holster so that patients can remain ambulatory.
Number of Adverse Events Number of adverse events	32 Number of adverse events	41 Number of adverse events
Number of Adverse Events Relationship to the product/ probably related	0 Number of adverse events	1 Number of adverse events
Number of Adverse Events Relationship to the product/unrelated	30 Number of adverse events	37 Number of adverse events
Number of Adverse Events Relationship to the product/Unlikely	1 Number of adverse events	2 Number of adverse events
Number of Adverse Events Relationship to the product/ Possibly related	1 Number of adverse events	1 Number of adverse events

Adverse Events

Standard of Care Arm

Serious events: 8 serious events

Other events: 13 other events

Deaths: 0 deaths

Intervention Arm

Serious events: 6 serious events

Other events: 19 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Standard of Care Arm n=64 participants at risk Patients in the standard of care arm will receive the standard care for their type of wound from their wound care centre which typically includes a primary and secondary dressing to the wound.	Intervention Arm n=81 participants at risk Patients in the intervention arm will receive standard of care plus Natrox® Oxygen Wound Therapy as treatment for their wound. Natrox® Oxygen Wound Therapy: A battery-operated device which delivers pure humidified oxygen to the wound bed through water electrolysis via a sterile oxygen delivery system.
Respiratory, thoracic and mediastinal disorders Shortness of Breath	4.7% 3/64 • Number of events 3 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.	0.00% 0/81 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.
Skin and subcutaneous tissue disorders Cellulitis	1.6% 1/64 • Number of events 1 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.	1.2% 1/81 • Number of events 1 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.
Infections and infestations Gangrene	1.6% 1/64 • Number of events 1 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.	1.2% 1/81 • Number of events 1 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.
Infections and infestations Infection	1.6% 1/64 • Number of events 1 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.	2.5% 2/81 • Number of events 2 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.
Blood and lymphatic system disorders Bacteremia	1.6% 1/64 • Number of events 1 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.	0.00% 0/81 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.
Musculoskeletal and connective tissue disorders Osteomyelitis	0.00% 0/64 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.	1.2% 1/81 • Number of events 1 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.
General disorders Pain	1.6% 1/64 • Number of events 1 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.	0.00% 0/81 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.
Metabolism and nutrition disorders Acute hypokalemic	0.00% 0/64 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.	1.2% 1/81 • Number of events 1 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.

Other adverse events

Other adverse events
Measure	Standard of Care Arm n=64 participants at risk Patients in the standard of care arm will receive the standard care for their type of wound from their wound care centre which typically includes a primary and secondary dressing to the wound.	Intervention Arm n=81 participants at risk Patients in the intervention arm will receive standard of care plus Natrox® Oxygen Wound Therapy as treatment for their wound. Natrox® Oxygen Wound Therapy: A battery-operated device which delivers pure humidified oxygen to the wound bed through water electrolysis via a sterile oxygen delivery system.
Skin and subcutaneous tissue disorders New Wound	10.9% 7/64 • Number of events 8 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.	7.4% 6/81 • Number of events 6 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.
Injury, poisoning and procedural complications Falls	3.1% 2/64 • Number of events 2 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.	4.9% 4/81 • Number of events 7 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.
Skin and subcutaneous tissue disorders Maceration	3.1% 2/64 • Number of events 4 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.	2.5% 2/81 • Number of events 2 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.
Infections and infestations Wound Infection	3.1% 2/64 • Number of events 2 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.	7.4% 6/81 • Number of events 6 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.
Infections and infestations Infections	4.7% 3/64 • Number of events 4 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.	1.2% 1/81 • Number of events 1 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.
Skin and subcutaneous tissue disorders Pain	1.6% 1/64 • Number of events 1 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.	3.7% 3/81 • Number of events 3 • During the12 week intervention period patients were monitored for adverse events. * Severity of adverse events: Mild, Moderate, Severe, Life Threatening. * Outcome: Recovered, Recovered with sequelae, Not recovered, Lost to follow-up, Death. * Relationship to product: Unrelated, Unlikely, Possibly related, Probably related. * Action taken: Continued, Interrupted time in study, Discontinued.

Additional Information

Dr Thomas Serena

Serena Group Inc

Phone: 671-945-5225

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place