Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers

NCT01291160 | Completed Phase 2 Results DMC

• 1 other identifier: EPF-409
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 14

Brief Summary

This is a multicenter, prospective, parallel, double-blinded, validation study of up to 12 weeks duration to evaluate the safety and effectiveness of EPIFLO for the treatment of Diabetic Foot Ulcer. The primary objectives of this study are: 1) to evaluate the effectiveness of EPIFLO in combination with standard wound therapy on wound healing as compared to standard wound therapy alone; and 2) Screening for potential safety issues. Diabetic subjects with a Diabetic Foot Ulcer present for a minimum of 30 days will be enrolled. All subjects enrolled in the study will receive a standard wound therapy regimen consisting of, wound cleansing, moist wound care, off-loading and as appropriate, aggressive debridement. Subjects will be randomized to either the Treatment arm or the Control arm. Subjects will be assessed weekly for signs of wound healing during the 12-week Treatment Period, once two weeks after wound closure and once at the end of 12-week durability Period.

Conditions

Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• Number of 100% Wound Closure

  before or at week 12

Study Arms (2)

Epiflo Treatment

EXPERIMENTAL

The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.

Device: Epiflo

Sham Device

SHAM COMPARATOR

The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.

Other: Moist Wound Therapy

Interventions

Epiflo DEVICE

During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.

Also known as: Transdermal Continuous Oxygen Therapy

Epiflo Treatment

Moist Wound Therapy OTHER

During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.

Sham Device

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients 20-90 years of age with type 1 or type 2 diabetes mellitus with non-healing, full-thickness, University of Texas Classification of Diabetic Foot Ulcers Class IA diabetic foot ulcers of at least 4 weeks duration, but not greater than 52 weeks, measuring 1 -10 cm2 in area (Area = length x width) 50% at least from 65+ age group
• Any diabetic foot ulcer at or below the malleoli
• Patients with partial amputation up to \& including a TMA
• Subjects; between 20-90 years of age with a diabetic foot ulcer; 50% at least from 65+ age group
• Subjects must have had the wound open for at least 4 weeks from day one on screening visit.
• Subjects wound must be ≥1 cm2 in size at screening visit, but not greater than 10 cm2.
• Subject's ABI should be ≥ 0.7 on the study limb or transcutaneous partial pressure oxygen (TcpO2) \>40mmHg; or a toe pressure ≥40mmHg; or a Doppler waveform consistent with adequate flow in the foot(biphasic or triphasic waveforms) at screening
• No active malignancy except non-melanoma skin cancer
• Subject and/or caregiver must be willing and able to learn and perform the duties of dressing changes, and demonstrate the ability to do so.
• If patient has had a history of alcohol or substance abuse within 6 months prior to base line period, should provide proof of treatment.

You may not qualify if:

• Wounds of duration \>52 weeks
• Evidence of gangrene on any part of affected limb;
• Subjects with active Charcot's foot on the study limb;
• Subjects scheduled to undergo vascular surgery, angioplasty or thrombolysis;
• Subjects with infected target ulcers, accompanied by cellulitis, known or suspected osteomyelitis, or other clinical evidence of infection;
• Index ulcer has exposed tendons, ligaments, muscle, or bone.
• ulcers present in between toes
• Target limb is infected at beginning of study
• Must never have had malignancy on study limb
• Oral, or IV antibiotic/antimicrobial agents or medications have been used within 2 days (48 hours) of baseline.
• Patients with steroids \>7mg dosage are excluded
• Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within two weeks of screening date.
• Subject may not be pregnant at the time of treatment.
• Subjects with ulcer that has a total Surface Area of greater than 10 cm2 at Screening Visit as measured by a member of the study staff;
• Subject is undergoing renal dialysis, has known immune insufficiency, other than Diabetes Mellitus

Sponsors & Collaborators

• Neogenix, LLC dba Ogenix: lead

Study Sites (14)

Carl T. Hayden VA Medical Center

Phoenix, Arizona, 85012, United States

Location

Southern AZ VA Health Care System

Tucson, Arizona, 85723, United States

Location

Dean Vayser, DPM

Encinitas, California, 92024, United States

Location

California School of Podiatric Medicine

Fresno, California, 93719, United States

Location

Unknown Facility

Los Angeles, California, 90010, United States

Location

Unknown Facility

San Jose, California, 95116, United States

Location

The Diabetic Foot

San Marcos, California, 92078-2427, United States

Location

UF College of Medicine-Jacksonville

Jacksonville, Florida, 32209, United States

Location

Bruce W. Carter Dept. of Veterans Affairs Medical Center, Miami VA Health Care System

Miami, Florida, 33125, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Ocean County Foot & Ankle Surgical Associates

Toms River, New Jersey, 08753, United States

Location

Ohio College of Podiatric Medicine

Independence, Ohio, 44131, United States

Location

Unknown Facility

San Antonio, Texas, 78212, United States

Location

Tacoma Diabetic Foot Center

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: S.Sarangapani
• Organization: Ogenix

ssarangapani@ogenix.com

7817026732

Study Officials

• Vickie R Driver, MSDPM FACFAS

  Lead Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 8, 2011
• Study Start: October 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 13, 2014
• Results First Posted: May 13, 2014

Record last verified: 2014-04

Locations

US (14)