Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ogenix Corporation
ClinicalTrials.gov Identifier:
NCT01291160
First received: February 4, 2011
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Diabetic Foot Ulcers
Device: Epiflo
Other: Moist Wound Therapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Blinded Multicenter, Parallel Study Comparing Transdermal, Continuous Oxygen Delivery to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by Ogenix Corporation:

Primary Outcome Measures:
  • Number of 100% Wound Closure [ Time Frame: before or at week 12 ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: October 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epiflo Treatment
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
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.
Other Name: Transdermal Continuous Oxygen Therapy
Sham Comparator: Sham Device
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
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.

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Ulcers which decrease in area by >30% during the screening 1-week run-in period
  • History of peripheral vascular repair within the 30 days of baseline.
  • Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
  • No known "patient-reported" alcohol or substance abuse within three months prior to baseline.
  • Subject currently enrolled or participated within 30 days of baseline in another investigational device, drug or biological trial.
  • Subject allergic to a broad spectrum of primary & secondary dressing materials,including occlusive dressings and the adhesives on such dressings.
  • Subject with Chopart amputation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291160

Locations
United States, Arizona
Carl T. Hayden VA Medical Center
Phoenix, Arizona, United States, 85012
Southern AZ VA Health Care System
Tucson, Arizona, United States, 85723
United States, California
Dean Vayser, DPM
Encinitas, California, United States, 92024
California School of Podiatric Medicine
Fresno, California, United States, 93719
Los Angeles, California, United States, 90010
San Jose, California, United States, 95116
The Diabetic Foot
San Marcos,, California, United States, 92078-2427
United States, Florida
UF College of Medicine-Jacksonville
Jacksonville, Florida, United States, 32209
Bruce W. Carter Dept. of Veterans Affairs Medical Center, Miami VA Health Care System
Miami, Florida, United States, 33125
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New Jersey
Ocean County Foot & Ankle Surgical Associates
Toms River,, New Jersey, United States, 08753
United States, Ohio
Ohio College of Podiatric Medicine
Independence, Ohio, United States, 44131
United States, Texas
San Antonio, Texas, United States, 78212
United States, Washington
Tacoma Diabetic Foot Center
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Ogenix Corporation
Investigators
Principal Investigator: Vickie R Driver, MSDPM FACFAS Lead Principal Investigator
  More Information

No publications provided

Responsible Party: Ogenix Corporation
ClinicalTrials.gov Identifier: NCT01291160     History of Changes
Other Study ID Numbers: EPF-409
Study First Received: February 4, 2011
Results First Received: April 11, 2014
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Foot
Foot Ulcer
Ulcer
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Diabetic Neuropathies
Endocrine System Diseases
Foot Diseases
Leg Ulcer
Pathologic Processes
Skin Diseases
Skin Ulcer
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014