Trial Outcomes & Findings for Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers (NCT NCT02427802)

NCT ID: NCT02427802

Last Updated: 2021-08-25

Results Overview

The primary efficacy variable is the percent of patients with a clinical outcome of clinical cure (Resolution of all clinical signs and symptoms of infection) at F/U visit 1

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 612 participants
• Primary outcome timeframe: approximately 10 days after end of treatment
• Results posted on: 2021-08-25

Participant Flow

Participant milestones

Measure	Gentamicin Sponge Group Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Gentamicin collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Placebo Sponge Group Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching collagen sponge	No Sponge Group Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Overall Study STARTED	305	154	153
Overall Study COMPLETED	246	120	110
Overall Study NOT COMPLETED	59	34	43

Reasons for withdrawal

Measure	Gentamicin Sponge Group Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Gentamicin collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Placebo Sponge Group Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching collagen sponge	No Sponge Group Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Overall Study Adverse Event	11	3	7
Overall Study Death	0	4	1
Overall Study Lost to Follow-up	13	8	8
Overall Study Physician Decision	4	2	4
Overall Study Withdrawal by Subject	10	5	11
Overall Study Protocol Violation	3	1	1
Overall Study protocol specific treatment unrelated	18	11	11

Baseline Characteristics

Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers

Baseline characteristics by cohort

Measure	Gentamicin Sponge Group n=305 Participants Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Gentamicin collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Placebo Sponge Group n=154 Participants Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching collagen sponge	No Sponge Group n=153 Participants Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.	Total n=612 Participants Total of all reporting groups
Age, Continuous	57.6 years STANDARD_DEVIATION 10.84 • n=5 Participants	57.1 years STANDARD_DEVIATION 11.12 • n=7 Participants	56.7 years STANDARD_DEVIATION 11.16 • n=5 Participants	57.3 years STANDARD_DEVIATION 10.98 • n=4 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	47 Participants n=7 Participants	34 Participants n=5 Participants	146 Participants n=4 Participants
Sex: Female, Male Male	240 Participants n=5 Participants	107 Participants n=7 Participants	119 Participants n=5 Participants	466 Participants n=4 Participants
Region of Enrollment United States	305 participants n=5 Participants	154 participants n=7 Participants	153 participants n=5 Participants	612 participants n=4 Participants

PRIMARY outcome

Timeframe: approximately 10 days after end of treatment

Population: modified intent to treat population consisted of randomized patients who received any dose of gentamicin-sponge or placebo-sponge or who were randomized to the no sponge arm, and who were not early-terminated for any of the treatment-unrelated reasons before F/U visit 1,

The primary efficacy variable is the percent of patients with a clinical outcome of clinical cure (Resolution of all clinical signs and symptoms of infection) at F/U visit 1

Outcome measures

Measure	Gentamicin Sponge Group n=283 Participants Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Gentamicin collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Placebo Sponge Group n=141 Participants Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching collagen sponge	No Sponge Group n=140 Participants Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Clinical Cure (Resolution of All Clinical Signs and Symptoms of Infection)	115 Participants	64 Participants	48 Participants

SECONDARY outcome

Timeframe: Approximately 10 days after end of treatment

Percent of patients with both a clinical outcome of clinical cure (Resolution of all clinical signs and symptoms of infection) and baseline pathogen eradication at F/U visit 1

Outcome measures

Measure	Gentamicin Sponge Group n=283 Participants Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Gentamicin collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Placebo Sponge Group n=141 Participants Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching collagen sponge	No Sponge Group n=140 Participants Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Clinical Cure and Baseline Pathogen Eradication (Resolution of All Clinical Signs and Symptoms of Infection) and Baseline Pathogen Eradication)	87 Participants	47 Participants	34 Participants

SECONDARY outcome

Timeframe: Approximately 90 days after end of treatment

Percent of patients with re-infection

Outcome measures

Measure	Gentamicin Sponge Group n=283 Participants Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Gentamicin collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Placebo Sponge Group n=141 Participants Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching collagen sponge	No Sponge Group n=140 Participants Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Reinfection (Percent of Patients With Re-infection)	12 Participants	5 Participants	2 Participants

SECONDARY outcome

Timeframe: Approximately 10 days after end of treatment

Population: Modified Intent-to-Treat Population

Actual time to clinical cure (Resolution of all clinical signs and symptoms of infection)

Outcome measures

Measure	Gentamicin Sponge Group n=140 Participants Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Gentamicin collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Placebo Sponge Group n=75 Participants Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching collagen sponge	No Sponge Group n=59 Participants Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Time to Clinical Cure	41 Days Interval 30.0 to Upper boundary not reached	33 Days Interval 29.0 to Upper boundary not reached	46 Days Interval 30.0 to Upper boundary not reached

SECONDARY outcome

Timeframe: Within approximately 90 days of end of treatment

Population: Modified Intent-to-Treat Population

Percent of patients that have an amputation associated with the target ulcer

Outcome measures

Measure	Gentamicin Sponge Group n=283 Participants Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Gentamicin collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Placebo Sponge Group n=141 Participants Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching collagen sponge	No Sponge Group n=140 Participants Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Amputation (Percent of Patients That Have an Amputation Associated With the Target Ulcer)	2 Participants	3 Participants	5 Participants

SECONDARY outcome

Timeframe: within approximately 30 days of end of treatment

Population: Modified Intent-to-Treat Population

Percent of patients with ulcer closure within approximately 30 days of end of treatment

Outcome measures

Measure	Gentamicin Sponge Group n=283 Participants Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Gentamicin collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Placebo Sponge Group n=141 Participants Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching collagen sponge	No Sponge Group n=140 Participants Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Ulcer Closure (Percent of Patients With Target Ulcer Closure)	67 Participants	32 Participants	29 Participants

Adverse Events

Gentamicin Sponge Group

Serious events: 44 serious events

Other events: 135 other events

Deaths: 0 deaths

Placebo Sponge Group

Serious events: 22 serious events

Other events: 72 other events

Deaths: 4 deaths

No Sponge Group

Serious events: 26 serious events

Other events: 65 other events

Deaths: 1 deaths

Serious adverse events

Measure	Gentamicin Sponge Group n=305 participants at risk Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Gentamicin collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Placebo Sponge Group n=154 participants at risk Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching collagen sponge	No Sponge Group n=153 participants at risk Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Infections and infestations osteomyelitis	2.3% 7/305 • Number of events 7 • approximately 28 days	2.6% 4/154 • Number of events 4 • approximately 28 days	4.6% 7/153 • Number of events 7 • approximately 28 days
Infections and infestations infected skin ulcer	2.3% 7/305 • Number of events 7 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	2.6% 4/153 • Number of events 4 • approximately 28 days
Infections and infestations cellulitis	1.3% 4/305 • Number of events 4 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	1.3% 2/153 • Number of events 2 • approximately 28 days
Infections and infestations osteomyelitis acute	0.98% 3/305 • Number of events 3 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	1.3% 2/153 • Number of events 2 • approximately 28 days
Infections and infestations sepsis	0.98% 3/305 • Number of events 3 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Infections and infestations abscess limb	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	1.3% 2/153 • Number of events 2 • approximately 28 days
Infections and infestations gangrene	0.33% 1/305 • Number of events 1 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Infections and infestations influenza	0.00% 0/305 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Infections and infestations localised infection	0.00% 0/305 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Infections and infestations osteomyelitis chronic	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Infections and infestations post procedural infection	0.00% 0/305 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.65% 1/153 • Number of events 1 • approximately 28 days
Infections and infestations postoperative wound infection	0.00% 0/305 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Infections and infestations streptococcal bacteraemia	0.00% 0/305 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.65% 1/153 • Number of events 1 • approximately 28 days
Blood and lymphatic system disorders cardiac failure congestive	1.3% 4/305 • Number of events 4 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Cardiac disorders cardiac arrest	0.00% 0/305 • approximately 28 days	1.3% 2/154 • Number of events 2 • approximately 28 days	0.00% 0/153 • approximately 28 days
Cardiac disorders coronary artery disease	0.33% 1/305 • Number of events 1 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Cardiac disorders acute myocardial infarction	0.00% 0/305 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Cardiac disorders angina pectoris	0.00% 0/305 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.65% 1/153 • Number of events 1 • approximately 28 days
Cardiac disorders cardiac failure acute	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Cardiac disorders mitral valve incompetence	0.00% 0/305 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Cardiac disorders myocardial infarction	0.00% 0/305 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Cardiac disorders pericardial effusion	0.00% 0/305 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Cardiac disorders ventricular tachycardia	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Renal and urinary disorders acute kidney injury	0.66% 2/305 • Number of events 2 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	1.3% 2/153 • Number of events 2 • approximately 28 days
Renal and urinary disorders chronic kidney disease	0.66% 2/305 • Number of events 2 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.65% 1/153 • Number of events 1 • approximately 28 days
Renal and urinary disorders haematuria	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Metabolism and nutrition disorders decreased appetite	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Metabolism and nutrition disorders diabetes mellitus inadequate cotnrol	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Metabolism and nutrition disorders diabetic ketoacidosis	0.00% 0/305 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.65% 1/153 • Number of events 1 • approximately 28 days
Metabolism and nutrition disorders hypokalaemia	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Metabolism and nutrition disorders hyponatraemia	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Metabolism and nutrition disorders metabolic acidosis	0.00% 0/305 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Metabolism and nutrition disorders type 2 diabetes mellitus	0.00% 0/305 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.65% 1/153 • Number of events 1 • approximately 28 days
Respiratory, thoracic and mediastinal disorders acute respiratory failure	0.33% 1/305 • Number of events 1 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Respiratory, thoracic and mediastinal disorders chronic obstructive pulmonary disease	0.00% 0/305 • approximately 28 days	1.3% 2/154 • Number of events 2 • approximately 28 days	0.00% 0/153 • approximately 28 days
Respiratory, thoracic and mediastinal disorders pulmonay embolism	0.00% 0/305 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.65% 1/153 • Number of events 1 • approximately 28 days
Respiratory, thoracic and mediastinal disorders pulmonary mass	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
General disorders asthenia	0.00% 0/305 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
General disorders chest pain	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
General disorders death	0.00% 0/305 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.65% 1/153 • Number of events 1 • approximately 28 days
General disorders device extrusion	0.00% 0/305 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.65% 1/153 • Number of events 1 • approximately 28 days
General disorders non-cardiac chest pain	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Skin and subcutaneous tissue disorders skin ulcer	0.98% 3/305 • Number of events 3 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Skin and subcutaneous tissue disorders decubitus ulcer	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Injury, poisoning and procedural complications head injury	0.00% 0/305 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
General disorders hip fracture	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Injury, poisoning and procedural complications limb injury	0.00% 0/305 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.65% 1/153 • Number of events 1 • approximately 28 days
Injury, poisoning and procedural complications stab wound	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Nervous system disorders syncope	0.66% 2/305 • Number of events 2 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Nervous system disorders diabetic hyperosmolar coma	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Nervous system disorders seizure	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.65% 1/153 • Number of events 1 • approximately 28 days
Nervous system disorders transient ischaemic attack	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Vascular disorders hypotension	0.00% 0/305 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Vascular disorders peripheral ischaemia	0.00% 0/305 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Vascular disorders peripheral vascular disorder	0.00% 0/305 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.65% 1/153 • Number of events 1 • approximately 28 days
Blood and lymphatic system disorders anaemia	0.66% 2/305 • Number of events 2 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Psychiatric disorders mental status changes	0.00% 0/305 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	0.00% 0/153 • approximately 28 days
Psychiatric disorders suicidal ideation	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Gastrointestinal disorders diabetic gastroparesis	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Gastrointestinal disorders impaired gastric emptying	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days
Hepatobiliary disorders cholecystitis acute	0.00% 0/305 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.65% 1/153 • Number of events 1 • approximately 28 days
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Mueller's mixed tumour	0.00% 0/305 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.65% 1/153 • Number of events 1 • approximately 28 days
Reproductive system and breast disorders penile necrosis	0.33% 1/305 • Number of events 1 • approximately 28 days	0.00% 0/154 • approximately 28 days	0.00% 0/153 • approximately 28 days

Other adverse events

Measure	Gentamicin Sponge Group n=305 participants at risk Topical Gentamicin Collagen Sponge: Up to four collagen sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base) administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Gentamicin collagen sponge: Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)	Placebo Sponge Group n=154 participants at risk Matching placebo collagen sponge administered daily, with systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days. Placebo: Matching collagen sponge	No Sponge Group n=153 participants at risk Systemic antibiotic therapy and standard ulcer care (gentamicin-sponge group) for up to 28 days.
Infections and infestations infected skin ulcer	7.5% 23/305 • Number of events 23 • approximately 28 days	7.1% 11/154 • Number of events 11 • approximately 28 days	5.2% 8/153 • Number of events 8 • approximately 28 days
Infections and infestations Osteomyelitis	3.3% 10/305 • Number of events 10 • approximately 28 days	5.2% 8/154 • Number of events 8 • approximately 28 days	6.5% 10/153 • Number of events 10 • approximately 28 days
Infections and infestations Cellulitis	2.3% 7/305 • Number of events 7 • approximately 28 days	2.6% 4/154 • Number of events 4 • approximately 28 days	2.6% 4/153 • Number of events 4 • approximately 28 days
Infections and infestations Urinary Tract Infection	0.98% 3/305 • Number of events 3 • approximately 28 days	2.6% 4/154 • Number of events 4 • approximately 28 days	2.6% 4/153 • Number of events 4 • approximately 28 days
Infections and infestations Sepsis	2.0% 6/305 • Number of events 6 • approximately 28 days	1.3% 2/154 • Number of events 2 • approximately 28 days	0.00% 0/153 • approximately 28 days
Infections and infestations Upper Respiratory tract infection	0.98% 3/305 • Number of events 3 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	2.0% 3/153 • Number of events 3 • approximately 28 days
Gastrointestinal disorders Nausea	7.2% 22/305 • Number of events 22 • approximately 28 days	8.4% 13/154 • Number of events 13 • approximately 28 days	3.9% 6/153 • Number of events 6 • approximately 28 days
Gastrointestinal disorders Diarrhoea	5.9% 18/305 • Number of events 18 • approximately 28 days	1.9% 3/154 • Number of events 3 • approximately 28 days	1.3% 2/153 • Number of events 2 • approximately 28 days
Gastrointestinal disorders Vomiting	2.3% 7/305 • Number of events 7 • approximately 28 days	3.9% 6/154 • Number of events 6 • approximately 28 days	1.3% 2/153 • Number of events 2 • approximately 28 days
Gastrointestinal disorders Constipation	0.66% 2/305 • Number of events 2 • approximately 28 days	1.3% 2/154 • Number of events 2 • approximately 28 days	2.0% 3/153 • Number of events 3 • approximately 28 days
Skin and subcutaneous tissue disorders skin ulcer	8.5% 26/305 • Number of events 26 • approximately 28 days	5.8% 9/154 • Number of events 9 • approximately 28 days	7.2% 11/153 • Number of events 11 • approximately 28 days
Skin and subcutaneous tissue disorders Blister	2.0% 6/305 • Number of events 6 • approximately 28 days	1.3% 2/154 • Number of events 2 • approximately 28 days	0.00% 0/153 • approximately 28 days
Metabolism and nutrition disorders Type 2 diabetes Mellitus	0.33% 1/305 • Number of events 1 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	2.0% 3/153 • Number of events 3 • approximately 28 days
Injury, poisoning and procedural complications Fall	1.6% 5/305 • Number of events 5 • approximately 28 days	4.5% 7/154 • Number of events 7 • approximately 28 days	0.65% 1/153 • Number of events 1 • approximately 28 days
Injury, poisoning and procedural complications Laceration	0.33% 1/305 • Number of events 1 • approximately 28 days	1.9% 3/154 • Number of events 3 • approximately 28 days	2.0% 3/153 • Number of events 3 • approximately 28 days
Injury, poisoning and procedural complications Skin abrasion	0.66% 2/305 • Number of events 2 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	2.6% 4/153 • Number of events 4 • approximately 28 days
Renal and urinary disorders Acute Kidney Injury	2.6% 8/305 • Number of events 8 • approximately 28 days	2.6% 4/154 • Number of events 4 • approximately 28 days	2.0% 3/153 • Number of events 3 • approximately 28 days
Ear and labyrinth disorders Vertigo	3.9% 12/305 • Number of events 12 • approximately 28 days	2.6% 4/154 • Number of events 4 • approximately 28 days	2.0% 3/153 • Number of events 3 • approximately 28 days
Musculoskeletal and connective tissue disorders Pain in extremity	1.3% 4/305 • Number of events 4 • approximately 28 days	2.6% 4/154 • Number of events 4 • approximately 28 days	0.00% 0/153 • approximately 28 days
Immune system disorders Drug Hypersensitivity	0.98% 3/305 • Number of events 3 • approximately 28 days	0.65% 1/154 • Number of events 1 • approximately 28 days	2.0% 3/153 • Number of events 3 • approximately 28 days

Additional Information

Lesley Russell, MBChB, MRCP, Chief Medical Officer

Innocoll

Phone: 484-406-5206

Email: lrussell@innocoll.com

Results disclosure agreements

• Principal investigator is a sponsor employee Results of the multicenter study had to be published prior to the publication of any site specific data.
• Publication restrictions are in place

Restriction type: OTHER