Trial Outcomes & Findings for Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers (NCT NCT01590758)

NCT ID: NCT01590758

Last Updated: 2017-06-14

Results Overview

The numbers of participants with Clinical Response, defined as resolution of infection, are reported.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 189 participants
• Primary outcome timeframe: 28 days
• Results posted on: 2017-06-14

Participant Flow

Subjects recruited at outpatient clinics and practices

No wash-out or run-in periods; eligible subjects were immediately assigned to treatment

Participant milestones

Measure	Topical Pexiganan Cream 0.8% Topical pexiganan cream 0.8%: 14 days of treatment + 14 days of follow-up (28-day trial period) Standard wound care: 28-day trial period	Topical Placebo Control Topical placebo cream: 14 days of treatment + 14 days of follow-up (28-day trial period) Standard wound care: 28-day trial period
Overall Study STARTED	85	104
Overall Study COMPLETED	80	97
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Measure	Topical Pexiganan Cream 0.8% Topical pexiganan cream 0.8%: 14 days of treatment + 14 days of follow-up (28-day trial period) Standard wound care: 28-day trial period	Topical Placebo Control Topical placebo cream: 14 days of treatment + 14 days of follow-up (28-day trial period) Standard wound care: 28-day trial period
Overall Study Withdrawal by Subject	0	3
Overall Study Physician Decision	1	2
Overall Study Lost to Follow-up	4	2

Baseline Characteristics

Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers

Baseline characteristics by cohort

Measure	Topical Pexiganan Cream 0.8% n=85 Participants Topical pexiganan cream 0.8%: 14 days of treatment Standard wound care: 28-day trial period	Topical Placebo Control n=104 Participants Topical placebo cream: 14 days of treatment Standard wound care: 28-day trial period	Total n=189 Participants Total of all reporting groups
Age, Continuous Age	59.22 years STANDARD_DEVIATION 10.14 • n=5 Participants	58.42 years STANDARD_DEVIATION 10.97 • n=7 Participants	58.78 years STANDARD_DEVIATION 10.58 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	31 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants	73 Participants n=7 Participants	136 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	39 Participants n=5 Participants	52 Participants n=7 Participants	91 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants	52 Participants n=7 Participants	98 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) White	64 Participants n=5 Participants	82 Participants n=7 Participants	146 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	85 participants n=5 Participants	104 participants n=7 Participants	189 participants n=5 Participants
Wound surface area <1 sq cm	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Wound surface area 1 - <2 sq cm	41 Participants n=5 Participants	52 Participants n=7 Participants	93 Participants n=5 Participants
Wound surface area >=2 sq cm	43 Participants n=5 Participants	51 Participants n=7 Participants	94 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: Intent-To-Treat

The numbers of participants with Clinical Response, defined as resolution of infection, are reported.

Outcome measures

Measure	Topical Pexiganan Cream 0.8% n=85 Participants Topical pexiganan cream 0.8%: 14 days of treatment	Topical Placebo Control n=104 Participants Topical placebo cream: 14 days of treatment
Number of Participants With Clinical Response	43 Participants	63 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Intent-To-Treat Microbiological (positive for baseline pathogens)

The numbers of participants with Microbiological Response, defined as eradication of all initial pathogens, are reported.

Outcome measures

Measure	Topical Pexiganan Cream 0.8% n=59 Participants Topical pexiganan cream 0.8%: 14 days of treatment	Topical Placebo Control n=76 Participants Topical placebo cream: 14 days of treatment
Number of Participants With Microbiological Success	16 Participants	28 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Safety

The numbers of participants with TEAEs, including those with Serious TEAEs, are reported

Outcome measures

Measure	Topical Pexiganan Cream 0.8% n=85 Participants Topical pexiganan cream 0.8%: 14 days of treatment	Topical Placebo Control n=104 Participants Topical placebo cream: 14 days of treatment
Number of Participants With Treatment-emergent Adverse Events (TEAE) Incidence of any TEAE	26 Participants	25 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAE) Incidence of Serious TEAE	9 Participants	3 Participants

Adverse Events

Topical Pexiganan Cream 0.8%

Serious events: 9 serious events

Other events: 6 other events

Deaths: 0 deaths

Topical Placebo Control

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Topical Pexiganan Cream 0.8% n=85 participants at risk Topical pexiganan cream 0.8%: 14 days of treatment	Topical Placebo Control n=104 participants at risk Topical placebo cream: 14 days of treatment
Infections and infestations Osteomyelitis	3.5% 3/85 • Number of events 3 • 28 days	0.00% 0/104 • 28 days
Infections and infestations Gangrene	2.4% 2/85 • Number of events 2 • 28 days	0.00% 0/104 • 28 days
Infections and infestations Infection	2.4% 2/85 • Number of events 2 • 28 days	0.00% 0/104 • 28 days
Infections and infestations Pneumonia	1.2% 1/85 • Number of events 1 • 28 days	0.00% 0/104 • 28 days
Infections and infestations Urosepsis	1.2% 1/85 • Number of events 1 • 28 days	0.00% 0/104 • 28 days
Metabolism and nutrition disorders Diabetes inadequate control	0.00% 0/85 • 28 days	0.96% 1/104 • Number of events 1 • 28 days
Metabolism and nutrition disorders Fluid overload	0.00% 0/85 • 28 days	0.96% 1/104 • Number of events 1 • 28 days
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	1.2% 1/85 • Number of events 1 • 28 days	0.00% 0/104 • 28 days
Renal and urinary disorders Renal failure	1.2% 1/85 • Number of events 1 • 28 days	0.96% 1/104 • Number of events 1 • 28 days

Other adverse events

Measure	Topical Pexiganan Cream 0.8% n=85 participants at risk Topical pexiganan cream 0.8%: 14 days of treatment	Topical Placebo Control n=104 participants at risk Topical placebo cream: 14 days of treatment
Infections and infestations Cellulitis	3.5% 3/85 • Number of events 3 • 28 days	0.96% 1/104 • Number of events 1 • 28 days
Infections and infestations Osteomyelitis	3.5% 3/85 • Number of events 3 • 28 days	1.9% 2/104 • Number of events 2 • 28 days
Skin and subcutaneous tissue disorders Skin ulcer	1.2% 1/85 • Number of events 1 • 28 days	3.8% 4/104 • Number of events 4 • 28 days

Additional Information

Robert J DeLuccia

Dipexium Pharmaceuticals, Inc

Phone: +19145226503

Email: delucciarj@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee If no multi-site publication within 18 months of study completion, Site shall have right to publish subject to: 1) Prior to submitting/presenting, Site shall provide Sponsor a copy; Sponsor shall have 60 days to review/comment. 2) Site shall remove any Confidential Information prior to submitting/presenting the materials. 3) Site shall further delay publication/presentation for up to 120 days to allow Sponsor to protect its interests in any Sponsor Inventions described in any such materials.
• Publication restrictions are in place

Restriction type: OTHER