Diabetic Foot Infection
Conditions
Keywords
Diabetic Foot Ulcer Infection
Brief 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.
Interventions
14 days of treatment
14 days of treatment
OTHERStandard wound care
14 days of treatment
Sponsors
Dipexium Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Response | 28 days | The numbers of participants with Clinical Response, defined as resolution of infection, are reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | 28 days | The numbers of participants with TEAEs, including those with Serious TEAEs, are reported |
| Number of Participants With Microbiological Success | 28 days | The numbers of participants with Microbiological Response, defined as eradication of all initial pathogens, are reported. |
Countries
United States
Participant flow
Recruitment details
Subjects recruited at outpatient clinics and practices
Pre-assignment details
No wash-out or run-in periods; eligible subjects were immediately assigned to treatment
Participants by arm
| Arm | Count |
|---|---|
| Topical Pexiganan Cream 0.8% Topical pexiganan cream 0.8%: 14 days of treatment
Standard wound care: 28-day trial period | 85 |
| Topical Placebo Control Topical placebo cream: 14 days of treatment
Standard wound care: 28-day trial period | 104 |
| Total | 189 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Topical Pexiganan Cream 0.8% | Total | Topical Placebo Control |
|---|---|---|---|
| Age, Continuous Age | 59.22 years STANDARD_DEVIATION 10.14 | 58.78 years STANDARD_DEVIATION 10.58 | 58.42 years STANDARD_DEVIATION 10.97 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants | 91 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 98 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 36 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 64 Participants | 146 Participants | 82 Participants |
| Region of Enrollment United States | 85 participants | 189 participants | 104 participants |
| Sex: Female, Male Female | 22 Participants | 53 Participants | 31 Participants |
| Sex: Female, Male Male | 63 Participants | 136 Participants | 73 Participants |
| Wound surface area 1 - <2 sq cm | 41 Participants | 93 Participants | 52 Participants |
| Wound surface area <1 sq cm | 1 Participants | 2 Participants | 1 Participants |
| Wound surface area >=2 sq cm | 43 Participants | 94 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 85 | 0 / 104 |
| other Total, other adverse events | 6 / 85 | 4 / 104 |
| serious Total, serious adverse events | 9 / 85 | 3 / 104 |
Outcome results
Primary
Number of Participants With Clinical Response
The numbers of participants with Clinical Response, defined as resolution of infection, are reported.
Time frame: 28 days
Population: Intent-To-Treat
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Topical Pexiganan Cream 0.8% | Number of Participants With Clinical Response | 43 Participants |
| Topical Placebo Control | Number of Participants With Clinical Response | 63 Participants |
Secondary
Number of Participants With Microbiological Success
The numbers of participants with Microbiological Response, defined as eradication of all initial pathogens, are reported.
Time frame: 28 days
Population: Intent-To-Treat Microbiological (positive for baseline pathogens)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Topical Pexiganan Cream 0.8% | Number of Participants With Microbiological Success | 16 Participants |
| Topical Placebo Control | Number of Participants With Microbiological Success | 28 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAE)
The numbers of participants with TEAEs, including those with Serious TEAEs, are reported
Time frame: 28 days
Population: Safety
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Topical Pexiganan Cream 0.8% | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Incidence of any TEAE | 26 Participants |
| Topical Pexiganan Cream 0.8% | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Incidence of Serious TEAE | 9 Participants |
| Topical Placebo Control | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Incidence of any TEAE | 25 Participants |
| Topical Placebo Control | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Incidence of Serious TEAE | 3 Participants |