Trial Outcomes & Findings for Prontosan Quality of Life Study in Patients With Chronic Leg Wound(s) (NCT NCT03369756)
NCT ID: NCT03369756
Last Updated: 2020-12-08
Results Overview
The Wound-QoL is a tool to measure disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which is assessed for the previous 7 days and is competed by the patient. It has 3 subscales that can assess "Body", "Psyche" and "Everyday Life". These subscales cover items 1 to 16. Item 17 is not part of any of the subscales. The Wound-QoL can be used in clinical and observational studies and in daily practice. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). A "Total" or "Global" score is the average of at least 13 completed questions, regardless of which questions were not completed. The average of each of the 3 subscales can be computed if no more than 1 item of the subscale is missing. The higher values represents more of an impact to the patient for that item.
TERMINATED
NA
43 participants
5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)
2020-12-08
Participant Flow
Participant milestones
| Measure |
Prontosan Solution and Gel
Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period
Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
COMPLETED
|
36
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prontosan Quality of Life Study in Patients With Chronic Leg Wound(s)
Baseline characteristics by cohort
| Measure |
Prontosan Solution and Gel
n=36 Participants
Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period
Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
|
|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 15.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)Population: All subjects who completed 4 weeks of treatment.
The Wound-QoL is a tool to measure disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which is assessed for the previous 7 days and is competed by the patient. It has 3 subscales that can assess "Body", "Psyche" and "Everyday Life". These subscales cover items 1 to 16. Item 17 is not part of any of the subscales. The Wound-QoL can be used in clinical and observational studies and in daily practice. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). A "Total" or "Global" score is the average of at least 13 completed questions, regardless of which questions were not completed. The average of each of the 3 subscales can be computed if no more than 1 item of the subscale is missing. The higher values represents more of an impact to the patient for that item.
Outcome measures
| Measure |
Prontosan Solution and Gel
n=36 Participants
Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period
Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
|
|---|---|
|
Wound-QoL Global Score
Week 1 / Baseline
|
2.41 score on a scale
Standard Deviation 0.99
|
|
Wound-QoL Global Score
Week 2
|
1.74 score on a scale
Standard Deviation 1.15
|
|
Wound-QoL Global Score
Week 3
|
1.51 score on a scale
Standard Deviation 0.95
|
|
Wound-QoL Global Score
Week 4
|
1.25 score on a scale
Standard Deviation 0.90
|
|
Wound-QoL Global Score
Week 5 / End
|
1.30 score on a scale
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: 5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)Population: All subjects who completed 4 weeks of treatment.
The Wound-QoL is a tool to measure disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which is assessed for the previous 7 days and is competed by the patient. It has 3 subscales that can assess "Body", "Psyche" and "Everyday Life". It can be used in clinical and observational studies and in daily practice. Subscale "Body" consists of Items #1 to #5. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). The average of the subscale can be computed if no more than 1 item of the subscale is missing. The higher values represents more of an impact to the patient for that item.
Outcome measures
| Measure |
Prontosan Solution and Gel
n=36 Participants
Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period
Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
|
|---|---|
|
Wound QoL Subscore; Body Dimension
Body Subscore change, Baseline / Week 1 to Week 2
|
-0.76 score on a scale
Standard Deviation 1.15
|
|
Wound QoL Subscore; Body Dimension
Body Subscore change, Baseline / Week 1 to Week 3
|
-0.93 score on a scale
Standard Deviation 1.28
|
|
Wound QoL Subscore; Body Dimension
Body Subscore change, Baseline / Week 1 to Week 4
|
-1.19 score on a scale
Standard Deviation 1.30
|
|
Wound QoL Subscore; Body Dimension
Body Subscore change, Baseline / Week 1 to End / Week 5
|
-1.17 score on a scale
Standard Deviation 1.21
|
SECONDARY outcome
Timeframe: 5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)Population: All subjects who completed 4 weeks of treatment.
The Wound-QoL is a tool to measure disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which is assessed for the previous 7 days and is competed by the patient. It has 3 subscales that can assess "Body", "Psyche" and "Everyday Life". It can be used in clinical and observational studies and in daily practice. Subscale "Psyche" consists of Items #Items #6 to #10. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). The average of the subscale can be computed if no more than 1 item of the subscale is missing. The higher values represents more of an impact to the patient for that item.
Outcome measures
| Measure |
Prontosan Solution and Gel
n=36 Participants
Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period
Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
|
|---|---|
|
Wound QoL Subscore; Psyche Dimension
Psyche Subscore change, Baseline / Week 1 to Week 2
|
-0.77 score on a scale
Standard Deviation 1.12
|
|
Wound QoL Subscore; Psyche Dimension
Psyche Subscore change, Baseline / Week 1 to Week 3
|
-1.04 score on a scale
Standard Deviation 1.13
|
|
Wound QoL Subscore; Psyche Dimension
Psyche Subscore change, Baseline / Week 1 to Week 4
|
-1.24 score on a scale
Standard Deviation 1.27
|
|
Wound QoL Subscore; Psyche Dimension
Psyche Subscore change, Baseline / Week 1 to End / Week 5
|
-1.26 score on a scale
Standard Deviation 1.14
|
SECONDARY outcome
Timeframe: 5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)Population: All subjects completing 4 weeks of treatment.
The Wound-QoL is a tool to measure disease-specific, health-related quality of life of patients with chronic wounds. It consists of 17 items on impairments which is assessed for the previous 7 days and is competed by the patient. It has 3 subscales that can assess "Body", "Psyche" and "Everyday Life". It can be used in clinical and observational studies and in daily practice. Subscale "Everyday Life" consists of Items #Items #11 to #16. Each individual item is rated on a scale ranging from 0 (not at all) to 4 (very much). The average of the subscale can be computed if no more than 1 item of the subscale is missing. Generally, the higher values represents more of an impact to the patient for that item.
Outcome measures
| Measure |
Prontosan Solution and Gel
n=36 Participants
Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period
Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
|
|---|---|
|
Wound QoL Subscore; Everyday Life Dimension
Everyday Life Subscore change, Baseline / Week 1 to Week 2
|
-0.58 score on a scale
Standard Deviation 1.05
|
|
Wound QoL Subscore; Everyday Life Dimension
Everyday Life Subscore change, Baseline / Week 1 to Week 3
|
-0.82 score on a scale
Standard Deviation 1.04
|
|
Wound QoL Subscore; Everyday Life Dimension
Everyday Life Subscore change, Baseline / Week 1 to Week 4
|
-1.11 score on a scale
Standard Deviation 1.11
|
|
Wound QoL Subscore; Everyday Life Dimension
Everyday Life Subscore change, Baseline / Week 1 to End / Week 5
|
-1.00 score on a scale
Standard Deviation 0.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 weeks overall (4 weeks of treatment and/or observations followed by a one-day visit at end of study in week 5)Population: All subjects who completed 4 weeks of treatment.
Change in wound size from Baseline/Week 1 to Final/Week 5. The change in the size of a wound will be evaluated using a disposable ruler to directly measure the overall wound dimensions at each scheduled visit to the study site (Weeks 1 and 5). These measurements will be done before any cleaning of the wound and after cleaning the wound (debridement).
Outcome measures
| Measure |
Prontosan Solution and Gel
n=36 Participants
Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period
Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
|
|---|---|
|
Wound Size
Pre-Debridement Wound Size Change (Baseline/Week 1 to Week 5 / End)
|
-6.6 wound surface area (cm^2)
Standard Deviation 18.3
|
|
Wound Size
Post-Debridement Wound Size Change(Baseline/Week 1 to Final/Week 5)
|
-8.2 wound surface area (cm^2)
Standard Deviation 19.2
|
Adverse Events
Prontosan Solution and Gel
Serious adverse events
| Measure |
Prontosan Solution and Gel
n=43 participants at risk
Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period
Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
|
|---|---|
|
General disorders
Back Pain
|
2.3%
1/43 • Number of events 1 • Screening through 4th week of treatment (5 weeks total).
All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
|
|
Infections and infestations
Cellulitis
|
2.3%
1/43 • Number of events 1 • Screening through 4th week of treatment (5 weeks total).
All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
|
|
Injury, poisoning and procedural complications
Compression Fracture
|
2.3%
1/43 • Number of events 1 • Screening through 4th week of treatment (5 weeks total).
All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
|
|
Injury, poisoning and procedural complications
Contusion
|
2.3%
1/43 • Number of events 1 • Screening through 4th week of treatment (5 weeks total).
All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
|
|
Injury, poisoning and procedural complications
Fall
|
2.3%
1/43 • Number of events 1 • Screening through 4th week of treatment (5 weeks total).
All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
|
|
Nervous system disorders
Neuralgia
|
2.3%
1/43 • Number of events 1 • Screening through 4th week of treatment (5 weeks total).
All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
|
Other adverse events
| Measure |
Prontosan Solution and Gel
n=43 participants at risk
Treatment with Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel over 4 week period
Prontosan Wound Irrigation Solution and Prontosan Wound Gel: Wound cleansing using Prontosan solution and gel
|
|---|---|
|
General disorders
Burning Sensation
|
25.6%
11/43 • Number of events 62 • Screening through 4th week of treatment (5 weeks total).
All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
|
|
General disorders
Pain
|
7.0%
3/43 • Number of events 13 • Screening through 4th week of treatment (5 weeks total).
All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
|
|
General disorders
Paraesthesia
|
2.3%
1/43 • Number of events 1 • Screening through 4th week of treatment (5 weeks total).
All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
|
|
Skin and subcutaneous tissue disorders
Burning Sensation
|
2.3%
1/43 • Number of events 1 • Screening through 4th week of treatment (5 weeks total).
All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
|
|
Skin and subcutaneous tissue disorders
Pain
|
2.3%
1/43 • Number of events 1 • Screening through 4th week of treatment (5 weeks total).
All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
|
|
Skin and subcutaneous tissue disorders
Pain of Skin
|
2.3%
1/43 • Number of events 10 • Screening through 4th week of treatment (5 weeks total).
All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
|
|
Skin and subcutaneous tissue disorders
Paraesthesia
|
9.3%
4/43 • Number of events 18 • Screening through 4th week of treatment (5 weeks total).
All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
2.3%
1/43 • Number of events 4 • Screening through 4th week of treatment (5 weeks total).
All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
|
|
Skin and subcutaneous tissue disorders
Sensitive Skin
|
2.3%
1/43 • Number of events 1 • Screening through 4th week of treatment (5 weeks total).
All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
2.3%
1/43 • Number of events 1 • Screening through 4th week of treatment (5 weeks total).
All reported adverse events were recorded. It was decided that only Prontosan related AEs, all SAEs, and ADEs would be coded by the Sponsor according to the final version of the SAP (v2.0 dated 04-Nov-2019).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution acknowledges and shall cause Investigator to acknowledge that Sponsor has the right to use the Study Results in any manner deemed appropriate to Sponsor's business interests, both during, and following termination of, this Agreement. Where Institution and/or Investigator require the use of the Study Results for publication, the Institution and/or Investigator shall seek the Sponsor's written approval which shall not be unreasonably withheld.
- Publication restrictions are in place
Restriction type: OTHER