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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01590758
Other study ID # DPX-305
Secondary ID
Status Completed
Phase Phase 3
First received April 27, 2012
Last updated April 10, 2017
Start date June 2014
Est. completion date August 2016

Study information

Verified date April 2017
Source Dipexium Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 189
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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:

1. IDSA-defined moderate infection.

2. IDSA-defined severe infection.

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.

Study Design


Intervention

Drug:
Topical pexiganan cream 0.8%
14 days of treatment
Topical placebo cream
14 days of treatment
Other:
Standard wound care
14 days of treatment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Dipexium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Response Clinical Response will be classified according to the Investigator's medical judgment as one of the following: infection resolved, infection not resolved, recurrent infection, or unevaluable. 28 days
Secondary Microbiological Success Microbiological Response to therapy will be categorized as one of the following: complete microbiological response, partial microbiological response, no microbiological response, colonization, superinfection, relapse, reinfection, unevaluable, or not applicable. 28 days
Secondary Incidence and severity of adverse events 28 days
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