OneStep-1: Pexiganan Versus Placebo Control for the Treatment of Mild Infections of Diabetic Foot Ulcers

• Sponsor: Dipexium Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01590758
• Collaborator: (none)
• Enrollment: 189
• Locations: 30
• Arms: 2
• Duration (Months): 26
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Infection	Drug: Topical pexiganan cream 0.8%; Drug: Topical placebo cream; Other: Standard wound care	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 189 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Multicenter, Superiority, Placebo-Controlled Phase 3 Study of Pexiganan Cream 0.8% Applied Twice Daily for 14 Days in the Treatment of Adults With Mild Infections of Diabetic Foot Ulcers
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Topical placebo control	Drug: Topical placebo cream; 14 days of treatment; Other: Standard wound care; 14 days of treatment
Experimental: Topical pexiganan cream 0.8%	Drug: Topical pexiganan cream 0.8%; 14 days of treatment; Other Names: MSI-78 ; Other: Standard wound care; 14 days of treatment

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Clinical Response [28 days]

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

Secondary Outcome Measures

1. Number of Participants With Microbiological Success [28 days]

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

2. Number of Participants With Treatment-emergent Adverse Events (TEAE) [28 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States
2		Glendale	Arizona	United States
3		Mesa	Arizona	United States
4		Tucson	Arizona	United States
5		Jonesboro	Arkansas	United States
6		Bakersfield	California	United States
7		Fair Oaks	California	United States
8		Fresno	California	United States
9		Los Angeles	California	United States
10		Boynton Beach	Florida	United States
11		Hialeah	Florida	United States
12		Miami	Florida	United States
13		North Miami Beach	Florida	United States
14		South Miami	Florida	United States
15		Lexington	Kentucky	United States
16		Baltimore	Maryland	United States
17		Cambridge	Massachusetts	United States
18		Missoula	Montana	United States
19		Las Vegas	Nevada	United States
20		Emerson	New Jersey	United States
21		Greenville	North Carolina	United States
22		Toledo	Ohio	United States
23		Pittsburgh	Pennsylvania	United States
24		Aiken	South Carolina	United States
25		Baytown	Texas	United States
26		Dallas	Texas	United States
27		McAllen	Texas	United States
28		McKinney	Texas	United States
29		San Antonio	Texas	United States
30		Salt Lake City	Utah	United States

Sponsors and Collaborators

• Dipexium Pharmaceuticals, Inc.

Investigators

• Study Director: Michael H. Silverman, MD, BioStrategics Consulting Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dipexium Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT01590758
• Other Study ID Numbers: DPX-305
• First Posted: May 3, 2012
• Last Update Posted: Jun 14, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Dipexium Pharmaceuticals, Inc.: Diabetic Foot Ulcer Infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; Diabetic Foot; Foot Ulcer; Pexiganan

Study Results

Participant Flow

Recruitment Details	Subjects recruited at outpatient clinics and practices
Pre-assignment Detail	No wash-out or run-in periods; eligible subjects were immediately assigned to treatment

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

Baseline Characteristics

Arm/Group Title	Topical Pexiganan Cream 0.8%	Topical Placebo Control	Total
Arm/Group Description	Topical pexiganan cream 0.8%: 14 days of treatment Standard wound care: 28-day trial period	Topical placebo cream: 14 days of treatment Standard wound care: 28-day trial period	Total of all reporting groups
Overall Participants	85	104	189
Age (years) [Mean (Standard Deviation) ]
Age	59.22 (10.14)	58.42 (10.97)	58.78 (10.58)
Sex: Female, Male (Count of Participants)
Female	22 25.9%	31 29.8%	53 28%
Male	63 74.1%	73 70.2%	136 72%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	39 45.9%	52 50%	91 48.1%
Not Hispanic or Latino	46 54.1%	52 50%	98 51.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.2%	0 0%	1 0.5%
Asian	1 1.2%	1 1%	2 1.1%
Native Hawaiian or Other Pacific Islander	0 0%	1 1%	1 0.5%
Black or African American	19 22.4%	17 16.3%	36 19%
White	64 75.3%	82 78.8%	146 77.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	3 2.9%	3 1.6%
Region of Enrollment (participants) [Number]
United States	85 100%	104 100%	189 100%
Wound surface area (Count of Participants)
<1 sq cm	1 1.2%	1 1%	2 1.1%
1 - <2 sq cm	41 48.2%	52 50%	93 49.2%
>=2 sq cm	43 50.6%	51 49%	94 49.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Clinical Response
Description	The numbers of participants with Clinical Response, defined as resolution of infection, are reported.
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

Intent-To-Treat

Arm/Group Title	Topical Pexiganan Cream 0.8%	Topical Placebo Control
Arm/Group Description	Topical pexiganan cream 0.8%: 14 days of treatment	Topical placebo cream: 14 days of treatment
Measure Participants	85	104
Count of Participants [Participants]	43 50.6%	63 60.6%

2. Secondary Outcome

Title	Number of Participants With Microbiological Success
Description	The numbers of participants with Microbiological Response, defined as eradication of all initial pathogens, are reported.
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Topical Pexiganan Cream 0.8%	Topical Placebo Control
Arm/Group Description	Topical pexiganan cream 0.8%: 14 days of treatment	Topical placebo cream: 14 days of treatment
Measure Participants	59	76
Count of Participants [Participants]	16 18.8%	28 26.9%

3. Secondary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (TEAE)
Description	The numbers of participants with TEAEs, including those with Serious TEAEs, are reported
Time Frame	28 days

Outcome Measure Data

Analysis Population Description

Safety

Arm/Group Title	Topical Pexiganan Cream 0.8%	Topical Placebo Control
Arm/Group Description	Topical pexiganan cream 0.8%: 14 days of treatment	Topical placebo cream: 14 days of treatment
Measure Participants	85	104
Incidence of any TEAE	26 30.6%	25 24%
Incidence of Serious TEAE	9 10.6%	3 2.9%

Adverse Events

Time Frame	28 days
Arm/Group Title	Topical Pexiganan Cream 0.8%		Topical Placebo Control
Arm/Group Description	Topical pexiganan cream 0.8%: 14 days of treatment		Topical placebo cream: 14 days of treatment
All Cause Mortality
	Topical Pexiganan Cream 0.8%		Topical Placebo Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/85 (0%)		0/104 (0%)
Serious Adverse Events
	Topical Pexiganan Cream 0.8%		Topical Placebo Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/85 (10.6%)		3/104 (2.9%)
Infections and infestations
Osteomyelitis	3/85 (3.5%)	3	0/104 (0%)	0
Gangrene	2/85 (2.4%)	2	0/104 (0%)	0
Infection	2/85 (2.4%)	2	0/104 (0%)	0
Pneumonia	1/85 (1.2%)	1	0/104 (0%)	0
Urosepsis	1/85 (1.2%)	1	0/104 (0%)	0
Metabolism and nutrition disorders
Diabetes inadequate control	0/85 (0%)	0	1/104 (1%)	1
Fluid overload	0/85 (0%)	0	1/104 (1%)	1
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain	1/85 (1.2%)	1	0/104 (0%)	0
Renal and urinary disorders
Renal failure	1/85 (1.2%)	1	1/104 (1%)	1
Other (Not Including Serious) Adverse Events
	Topical Pexiganan Cream 0.8%		Topical Placebo Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/85 (7.1%)		4/104 (3.8%)
Infections and infestations
Cellulitis	3/85 (3.5%)	3	1/104 (1%)	1
Osteomyelitis	3/85 (3.5%)	3	2/104 (1.9%)	2
Skin and subcutaneous tissue disorders
Skin ulcer	1/85 (1.2%)	1	4/104 (3.8%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.