Trial · NCT01594762

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

NCT01594762, Phase 3, Completed, Dipexium Pharmaceuticals, Inc.; results first posted 2017-06-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers. Trials, record NCT01594762. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01594762

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers
NCT number: NCT01594762
Status: Completed
Phases: Phase 3
Enrollment: 200 participants, actual
Lead sponsor: Dipexium Pharmaceuticals, Inc.
Conditions: Diabetic Foot Infection
Interventions: Topical pexiganan cream 0.8%, Topical placebo cream, Standard wound care
First posted: 2012-05-09
Last updated: 2017-06-14
Results first posted: 2017-06-14

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Clinical Response	28 days	The numbers of participants with Clinical Response, defined as resolution of infection, are reported.
Secondary	Number of Participants With Microbiological Response	28 days	The numbers of participants with Microbiological Response, defined are eradication of all baseline pathogens, are reported.
Secondary	Number of Participants With Treatment-Emergent Adverse Events (TEAE)	28 days	The number of participants with TEAEs, including Serious TEAEs, are reported

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Clinical Response	28 days	Intent-To-Treat	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Microbiological Response	28 days	Intent-To-Treat Microbiological (positive for baseline pathogens)	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Treatment-Emergent Adverse Events (TEAE)	28 days	Safety	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants With Clinical Response	Topical Pexiganan Cream 0.8%		56	Participants
Number of Participants With Clinical Response	Topical Placebo Control		54	Participants
Number of Participants With Microbiological Response	Topical Pexiganan Cream 0.8%		18	Participants
Number of Participants With Microbiological Response	Topical Placebo Control		27	Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAE)	Topical Pexiganan Cream 0.8%	Incidence of any TEAE	25	Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAE)	Topical Placebo Control	Incidence of any TEAE	21	Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAE)	Topical Pexiganan Cream 0.8%	Incidence of Serious TEAE	8	Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAE)	Topical Placebo Control	Incidence of Serious TEAE	2	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Topical Pexiganan Cream 0.8%	97
Overall Study	STARTED	Topical Placebo Control	103
Overall Study	COMPLETED	Topical Pexiganan Cream 0.8%	86
Overall Study	COMPLETED	Topical Placebo Control	93
Overall Study	NOT COMPLETED	Topical Pexiganan Cream 0.8%	11
Overall Study	NOT COMPLETED	Topical Placebo Control	10

Source ClinicalTrials.gov

Adverse events20

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Osteomyelitis	Infections and infestations	Topical Pexiganan Cream 0.8%	3	97	3
other	Osteomyelitis	Infections and infestations	Topical Placebo Control	0	103	0
other	Dyspnoea	Respiratory, thoracic and mediastinal disorders	Topical Pexiganan Cream 0.8%	3	97	3
other	Dyspnoea	Respiratory, thoracic and mediastinal disorders	Topical Placebo Control	0	103	0
serious	Acute myocardial infarction	Cardiac disorders	Topical Pexiganan Cream 0.8%	1	97	1
serious	Acute myocardial infarction	Cardiac disorders	Topical Placebo Control	0	103	0
serious	Cellulitis	Infections and infestations	Topical Pexiganan Cream 0.8%	2	97	2
serious	Cellulitis	Infections and infestations	Topical Placebo Control	1	103	1
serious	Osteomyelitis	Infections and infestations	Topical Pexiganan Cream 0.8%	2	97	2
serious	Osteomyelitis	Infections and infestations	Topical Placebo Control	1	103	1

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Topical Pexiganan Cream 0.8%	0	97
Total, all-cause mortality	Topical Placebo Control	0	103
Total, other adverse events	Topical Pexiganan Cream 0.8%	6	97
Total, other adverse events	Topical Placebo Control	0	103
Total, serious adverse events	Topical Pexiganan Cream 0.8%	8	97
Total, serious adverse events	Topical Placebo Control	2	103

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
36781451	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Topical Pexiganan Cream 0.8% vs Topical Placebo Control: Number of Participants With Microbiological Response	Trial comparisons
Topical Pexiganan Cream 0.8% vs Topical Placebo Control: Number of Participants With Clinical Response	Trial comparisons
Topical Pexiganan Cream 0.8% vs Topical Placebo Control: deaths from any cause	Trial comparisons
Topical Pexiganan Cream 0.8% vs Topical Placebo Control: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01594762

GET https://conductscience.org/api/trials/v1/NCT01594762/registered

API reference For AI assistants