CClinicalTrials.gg
Sign In
CompletedNCT01594762OneStep-2Updated Jun 14, 2017Results posted

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

A Phase 3 interventional study of Topical pexiganan cream 0.8% and Topical placebo cream in Diabetic Foot Infection, sponsored by Dipexium Pharmaceuticals, Inc.. Completed at 39 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-14.

Sponsored by Dipexium Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to establish the clinical superiority and the safety of topical pexiganan cream 0.8% plus standard local wound care as compared to placebo cream plus standard local wound care, in the treatment of mildly infected diabetic foot ulcers.

02

Conditions studied

  • Diabetic Foot Infection

Keywords

  • Diabetic Foot Ulcer Infection
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 200 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Dipexium Pharmaceuticals, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diabetes mellitus.
  2. Male or female at least 18 years old.
  3. Subject must agree to adhere to all protocol procedures and return for all scheduled visits, and must be willing and able to provide written informed consent.
  4. Subject is to be treated on an outpatient basis.
  5. Full thickness ulcer or a partial thickness ulcer on the foot distal to the malleoli with a surface area ≥ 1 cm2 after the wound has undergone appropriate debridement.
  6. Localized mild infection of the ulcer.
  7. The diagnosis of mild infection must be confirmed immediately following debridement at Baseline.
  8. Subject must have plain radiographs taken within 2 days prior to entry showing no evidence of bony abnormalities consistent with osteomyelitis, or gas compatible with tissue crepitus, in the affected foot.

Exclusion criteria

Exclusion Criteria:

  1. IDSA-defined moderate infection, including cellulitis extending > 2 cm; lymphangitis; spread beneath the fascia; deep tissue abscess; gangrene; muscle, joint, or bone involvement.
  2. IDSA-defined severe infection, including systemic toxicity or metabolic instability.
  3. Infected diabetic foot ulcer that is associated with local wound complications such as prosthetic materials or protruding surgical hardware.
  4. > 1 infected foot ulcer.
  5. Subject is currently receiving topical antimicrobial treatment for a localized infection of the study ulcer and whose infection is improving in response to treatment.
  6. Subject has received a systemic antibiotic within 48 hours prior to Screening.
  7. Concurrent or expected to require systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
  8. Bone or joint involvement is suspected based on clinical examination or plain X-ray.
  9. Clinically significant peripheral arterial disease requiring vascular intervention.
  10. Subject is expected to be unable to care for the ulcer or return for all scheduled visits because of hospitalization, vacation, disability, etc. during the study period, or is unable to safely monitor the infection status at home.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
200 participants (actual)

Study arms

  • Placebo comparator
    Topical placebo control

    Drug: Topical placebo cream

    Drug: Topical placebo cream · Other: Standard wound care

  • Experimental
    Topical pexiganan cream 0.8%

    Drug: Topical pexiganan cream 0.8%

    Drug: Topical pexiganan cream 0.8% · Other: Standard wound care

Interventions

  • DrugTopical pexiganan cream 0.8%

    14 days of treatment

    Also known as: MSI-78

  • DrugTopical placebo cream

    14 days of treatment

  • OtherStandard wound care

    14 days of treatment

06

What researchers measure

Primary outcomes

  1. Number of Participants With Clinical Response

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

    Time frame: 28 days

Secondary outcomes

  1. Number of Participants With Microbiological Response

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

    Time frame: 28 days

  2. Number of Participants With Treatment-Emergent Adverse Events (TEAE)

    The number of participants with TEAEs, including Serious TEAEs, are reported

    Time frame: 28 days

07

Results

Posted Jun 14, 2017

Participant flow

Participant flow — Overall Study
MilestoneTopical Pexiganan Cream 0.8%Topical Placebo Control
Started97103
Completed8693
Not completed1110
Withdrew: Withdrawal by subject10
Withdrew: Lost to follow-up1010

Outcome measures

PrimaryNumber of Participants With Clinical Response

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

Time frame:
28 days
Reported as:
Count of participants · Participants
Number of Participants With Clinical Response
ParticipantsTopical Pexiganan Cream 0.8%Topical Placebo Control
Number of Participants With Clinical Response5654
SecondaryNumber of Participants With Microbiological Response

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

Time frame:
28 days
Reported as:
Count of participants · Participants
Number of Participants With Microbiological Response
ParticipantsTopical Pexiganan Cream 0.8%Topical Placebo Control
Number of Participants With Microbiological Response1827
SecondaryNumber of Participants With Treatment-Emergent Adverse Events (TEAE)

The number of participants with TEAEs, including Serious TEAEs, are reported

Time frame:
28 days
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAE)
ParticipantsTopical Pexiganan Cream 0.8%Topical Placebo Control
Incidence of any TEAE2521
Incidence of Serious TEAE82

Adverse events

Collected over 28 days. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Topical Pexiganan Cream 0.8%0/97 (0%)8/97 (8.2%)6/97 (6.2%)
Topical Placebo Control0/103 (0%)2/103 (1.9%)0/103 (0%)
Most frequent serious events
Most frequent serious events
EventTopical Pexiganan Cream 0.8%Topical Placebo Control
CellulitisInfections and infestations2/971/103
OsteomyelitisInfections and infestations2/971/103
DyspnoeaRespiratory, thoracic and mediastinal disorders2/970/103
Acute myocardial infarctionCardiac disorders1/970/103
Diabetic ketoacidiosisMetabolism and nutrition disorders1/970/103
LethargyNervous system disorders1/970/103
Skin necrosisSkin and subcutaneous tissue disorders1/970/103
Foot surgerySurgical and medical procedures1/970/103
Most frequent other events
Most frequent other events
EventTopical Pexiganan Cream 0.8%Topical Placebo Control
OsteomyelitisInfections and infestations3/970/103
DyspnoeaRespiratory, thoracic and mediastinal disorders3/970/103

Baseline characteristics

Age, Continuous
Age, Continuous(years)Topical Pexiganan Cream 0.8%Topical Placebo ControlTotal
Mean57.37 ± 12.7157.14 ± 10.6157.25 ± 11.65
Sex: Female, Male
Sex: Female, Male(Participants)Topical Pexiganan Cream 0.8%Topical Placebo ControlTotal
Female272249
Male7081151
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Topical Pexiganan Cream 0.8%Topical Placebo ControlTotal
Hispanic or Latino313566
Not Hispanic or Latino6668134
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Topical Pexiganan Cream 0.8%Topical Placebo ControlTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American192746
White7875153
More than one race000
Unknown or Not Reported011
Region of Enrollment
Region of Enrollment(participants)Topical Pexiganan Cream 0.8%Topical Placebo ControlTotal
United States97103200
Wound surface area
Wound surface area(Participants)Topical Pexiganan Cream 0.8%Topical Placebo ControlTotal
<1 sq cm459
1 - <2 sq cm5054104
>=2 sq cm434386
Missing011
08

Study locations

39 sites
  • Phoenix, Arizona, United States
  • Tucson, Arizona, United States
  • Jonesboro, Arkansas, United States
  • Castro Valley, California, United States
  • Davis, California, United States
  • Los Angeles, California, United States
  • Napa, California, United States
  • San Francisco, California, United States
  • Santa Rosa, California, United States
  • Sylmar, California, United States
  • Vacaville, California, United States
  • Norwalk, Connecticut, United States
  • Coral Gables, Florida, United States
  • Doral, Florida, United States
  • Hialeah, Florida, United States
  • Homestead, Florida, United States
  • Jacksonville, Florida, United States
  • Largo, Florida, United States
  • Miami Lakes, Florida, United States
  • Miami Shores, Florida, United States
  • Miami, Florida, United States
  • Pinellas Park, Florida, United States
  • Evans, Georgia, United States
  • North Chicago, Illinois, United States
  • Hutchinson, Kansas, United States
  • New Orleans, Louisiana, United States
  • Mineola, New York, United States
  • Charlotte, North Carolina, United States
  • Wilmington, North Carolina, United States
  • Duncansville, Pennsylvania, United States
  • York, Pennsylvania, United States
  • Columbia, South Carolina, United States
  • El Paso, Texas, United States
  • Fort Worth, Texas, United States
  • Lewisville, Texas, United States
  • Saint George, Utah, United States
  • Salt Lake City, Utah, United States
  • Roanoke, Virginia, United States
  • Richland, Washington, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01594762
Lead sponsor
Dipexium Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
May 9, 2012
Start date
Jun 2014
Primary completion
Jul 2016
Completion
Jul 2016
Results posted
Jun 14, 2017
Last update
Jun 14, 2017

Study contacts

Michael H. Silverman, MD
study director · Biostrategics Consulting Ltd

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Infections→

Other studies from this sponsor

Dipexium Pharmaceuticals, Inc.

Start the discussion