Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers



Status:Recruiting
Conditions:Gastrointestinal, Podiatry, Diabetes
Therapuetic Areas:Endocrinology, Gastroenterology, Orthopedics / Podiatry
Healthy:No
Age Range:20 - 90
Updated:3/30/2013
Start Date:October 2009
Contact:Vickie R Driver, MSDPM FACFAS
Email:Vickie.Driver@bmc.org
Phone:617-414-6828

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A Prospective, Randomized Blinded Multicenter, Parallel Study Comparing Transdermal, Continuous Oxygen Delivery to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Ulcers


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.


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
We found this trial at
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Washington, District of Columbia 20016
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1 Boston Medical Center Pl
Boston, Massachusetts 02118
617.638.8000
Boston Med Center Boston Medical Center (BMC) is a 496-bed academic medical center located in...
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Encinitas, California 92024
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Fresno, California 93719
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Independence, Ohio 44131
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Jacksonville, Florida 32209
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Phoenix, Arizona 85012
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San Marcos,, California 92078
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101 E Wood St
Spartanburg, South Carolina 29303
(864) 560-6000
Spartanburg Regional Medical Center Spartanburg Regional is an integrated healthcare delivery system that provides care...
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Tacoma, Washington 98405
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Toms River, New Jersey 08753
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