OneStep-2: 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: NCT01594762
• Collaborator: (none)
• Enrollment: 200
• Locations: 39
• Arms: 2
• Duration (Months): 25
• Patients Per Site: 5.1
• 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: 200 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: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Topical placebo control Drug: Topical placebo cream	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%	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 Response [28 days]

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

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

   The number of participants with TEAEs, including 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, 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Phoenix	Arizona	United States
2		Tucson	Arizona	United States
3		Jonesboro	Arkansas	United States
4		Castro Valley	California	United States
5		Davis	California	United States
6		Los Angeles	California	United States
7		Napa	California	United States
8		San Francisco	California	United States
9		Santa Rosa	California	United States
10		Sylmar	California	United States
11		Vacaville	California	United States
12		Norwalk	Connecticut	United States
13		Coral Gables	Florida	United States
14		Doral	Florida	United States
15		Hialeah	Florida	United States
16		Homestead	Florida	United States
17		Jacksonville	Florida	United States
18		Largo	Florida	United States
19		Miami Lakes	Florida	United States
20		Miami Shores	Florida	United States
21		Miami	Florida	United States
22		Pinellas Park	Florida	United States
23		Evans	Georgia	United States
24		North Chicago	Illinois	United States
25		Hutchinson	Kansas	United States
26		New Orleans	Louisiana	United States
27		Mineola	New York	United States
28		Charlotte	North Carolina	United States
29		Wilmington	North Carolina	United States
30		Duncansville	Pennsylvania	United States
31		York	Pennsylvania	United States
32		Columbia	South Carolina	United States
33		El Paso	Texas	United States
34		Fort Worth	Texas	United States
35		Lewisville	Texas	United States
36		Saint George	Utah	United States
37		Salt Lake City	Utah	United States
38		Roanoke	Virginia	United States
39		Richland	Washington	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: NCT01594762
• Other Study ID Numbers: DPX-306
• First Posted: May 9, 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

Arm/Group Title	Topical Pexiganan Cream 0.8%	Topical Placebo Control
Arm/Group Description	Drug: Topical pexiganan cream 0.8% 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	Drug: Topical placebo cream 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	97	103
COMPLETED	86	93
NOT COMPLETED	11	10

Baseline Characteristics

Arm/Group Title	Topical Pexiganan Cream 0.8%	Topical Placebo Control	Total
Arm/Group Description	Drug: Topical pexiganan cream 0.8% Topical pexiganan cream 0.8%: 14 days of treatment Standard wound care: 28-day trial period	Drug: Topical placebo cream Topical placebo cream: 14 days of treatment Standard wound care: 28-day trial period	Total of all reporting groups
Overall Participants	97	103	200
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.37 (12.71)	57.14 (10.61)	57.25 (11.65)
Sex: Female, Male (Count of Participants)
Female	27 27.8%	22 21.4%	49 24.5%
Male	70 72.2%	81 78.6%	151 75.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	31 32%	35 34%	66 33%
Not Hispanic or Latino	66 68%	68 66%	134 67%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	19 19.6%	27 26.2%	46 23%
White	78 80.4%	75 72.8%	153 76.5%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 1%	1 0.5%
Region of Enrollment (participants) [Number]
United States	97 100%	103 100%	200 100%
Wound surface area (Count of Participants)
<1 sq cm	4 4.1%	5 4.9%	9 4.5%
1 - <2 sq cm	50 51.5%	54 52.4%	104 52%
>=2 sq cm	43 44.3%	43 41.7%	86 43%
Missing	0 0%	1 1%	1 0.5%

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	Drug: Topical pexiganan cream 0.8% Topical pexiganan cream 0.8%: 14 days of treatment	Drug: Topical placebo cream Topical placebo cream: 14 days of treatment
Measure Participants	97	103
Count of Participants [Participants]	56 57.7%	54 52.4%

2. Secondary Outcome

Title	Number of Participants With Microbiological Response
Description	The numbers of participants with Microbiological Response, defined are eradication of all baseline 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	Drug: Topical pexiganan cream 0.8% Topical pexiganan cream 0.8%: 14 days of treatment	Drug: Topical placebo cream Topical placebo cream: 14 days of treatment
Measure Participants	63	75
Count of Participants [Participants]	18 18.6%	27 26.2%

3. Secondary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (TEAE)
Description	The number of participants with TEAEs, including 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	Drug: Topical pexiganan cream 0.8% Topical pexiganan cream 0.8%: 14 days of treatment	Drug: Topical placebo cream Topical placebo cream: 14 days of treatment
Measure Participants	97	103
Incidence of any TEAE	25 25.8%	21 20.4%
Incidence of Serious TEAE	8 8.2%	2 1.9%

Adverse Events

Time Frame	28 days
Arm/Group Title	Topical Pexiganan Cream 0.8%		Topical Placebo Control
Arm/Group Description	Drug: Topical pexiganan cream 0.8% Topical pexiganan cream 0.8%: 14 days of treatment		Drug: Topical placebo cream 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	0/97 (0%)		0/103 (0%)
Serious Adverse Events
	Topical Pexiganan Cream 0.8%		Topical Placebo Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/97 (8.2%)		2/103 (1.9%)
Cardiac disorders
Acute myocardial infarction	1/97 (1%)	1	0/103 (0%)	0
Infections and infestations
Cellulitis	2/97 (2.1%)	2	1/103 (1%)	1
Osteomyelitis	2/97 (2.1%)	2	1/103 (1%)	1
Metabolism and nutrition disorders
Diabetic ketoacidiosis	1/97 (1%)	1	0/103 (0%)	0
Nervous system disorders
Lethargy	1/97 (1%)	1	0/103 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea	2/97 (2.1%)	2	0/103 (0%)	0
Skin and subcutaneous tissue disorders
Skin necrosis	1/97 (1%)	1	0/103 (0%)	0
Surgical and medical procedures
Foot surgery	1/97 (1%)	1	0/103 (0%)	0
Other (Not Including Serious) Adverse Events
	Topical Pexiganan Cream 0.8%		Topical Placebo Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/97 (6.2%)		0/103 (0%)
Infections and infestations
Osteomyelitis	3/97 (3.1%)	3	0/103 (0%)	0
Respiratory, thoracic and mediastinal disorders
Dyspnoea	3/97 (3.1%)	3	0/103 (0%)	0

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.