- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02844660
Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers
A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Umbilical Cord Allograft in the Management of Diabetic Foot Ulcers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35205
- Central Research Associates
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Arizona
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Tucson, Arizona, United States, 85710
- Arizona Regional Medical Research (ARMR)
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California
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Carlsbad, California, United States, 92009
- ILD Research
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Fresno, California, United States, 93710
- Limb Preservation Platform, Inc
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Los Angeles, California, United States, 90057
- Foot and Ankle Clinic
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Florida
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Miami, Florida, United States, 33143
- Doctors Research Network
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Georgia
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Augusta, Georgia, United States, 30909
- Joseph M. Still Burn Center at Doctors Hospital
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Louisiana
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New Orleans, Louisiana, United States, 70121
- Ochsner Clinic Foundation
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Nevada
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Las Vegas, Nevada, United States, 89119
- Advanced Foot & Ankle Center
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Pennsylvania
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Haverford, Pennsylvania, United States, 19041
- Foot and Ankle Center
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Texas
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McAllen, Texas, United States, 78501
- Futuro Clinical Trials
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Virginia
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Hampton, Virginia, United States, 23666
- Ambulatory Foot & Ankle Center, PC
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Virginia Beach, Virginia, United States, 23464
- Costal Podiatry
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. Subject has a known history of Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
2. Index ulcer characteristics:
a. Ulcer present for ≥ 30 days prior to randomization (Day 0) b. Index ulcer is located below the ankle c. Index ulcer area after debridement is ≥ 1 cm² and ≤ 15 cm² at the randomization visit 3. Subject has completed 14-day run-in period with ≤ 30% wound area reduction post-debridement.
4. Subject has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
- Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30 mmHg, OR
- ABIs with results of ≥ 0.7 and ≤ 1.2, OR
Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot 5. Age ≥ 18 6. The subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study
Index Ulcer Assessment:
- Penetrates down totendon, or bone
- Presence of another diabetic foot ulcer within 3 cm of the index ulcer
- Index ulcer determined to be due to active Charcot deformity or major structural abnormalities of the foot
- Exhibits clinical signs and symptoms of infection
- Known or suspected local skin malignancy to the index diabetic ulcer
- Wound duration > one year without intermittent closure
Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment:
- In the last 7 days - Negative pressure wound therapy (wound vac or SNaP®) of the index ulcer
- In the last 7 days - Hyperbaric oxygen (HBO) therapy
- In the last 10 days - Chemical debridement, Dakin's solution, medical honey therapy
- In the last 30 days - Treatment with cytotoxic chemotherapy, application of topical steroids to the ulcer surface, or use of ≥ 14 days of immune-suppressants (including systemic corticosteroids); or, subject is anticipated to require such medications during the course of the study
- In the last 30 days - study ulcer treatment with any biological skin substitutes, including EpiCord, biomedical or topical growth factors, tissue engineered materials (e.g. Apligraf® or Dermagraft®), or other scaffold materials (e.g. OASIS® Wound Matrix, MatriStem® Wound Matrix, Grafix, etc.)
- In the last 30 days - Subject has been on any investigational drug(s) or therapeutic device(s)
- In the last 6 months - Amputation or revascularization (surgical or stenting) to the affected leg or foot
Subject criteria that will make subject ineligible for enrollment:
- Known osteomyelitis or active cellulitis at wound site
- Hemoglobin A1C >12 in the last 60 days prior to randomization
- History of Immune system disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or HIV
- Allergy or known sensitivity to Aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate
- Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator
- Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)
- Known history of poor compliance with medical treatments
- Subjects currently enrolled in this study. Concurrent enrollment in the study is prohibited
- Subjects currently receiving radiation therapy or chemotherapy
- Patients currently on dialysis or planning to start dialysis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EpiCord
Weekly application of EpiCord and standard of care (moist wound therapy and offloading)
|
Weekly application of EpiCord and standard of care (moist wound therapy and offloading)
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Active Comparator: Standard of Care
Weekly application of moist wound therapy and offloading
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moist wound therapy and offloading
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Ulcer Closure
Time Frame: 12 weeks
|
The percentage of subjects with complete closure of the study ulcer as assessed by photographic evaluation
|
12 weeks
|
Study Safety Measurement
Time Frame: 12 weeks
|
The proportion of product related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events at 12 weeks.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to complete closure
Time Frame: up to 12 weeks
|
As assessed by photographic evaluation and the Investigator
|
up to 12 weeks
|
Rate of wound closure
Time Frame: up to 12 weeks
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As assessed by photographic evaluation and the Investigator
|
up to 12 weeks
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Incidence of ulcer recurrence
Time Frame: up to 12 weeks
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Incidence of ulcer recurrence at the site of the study ulcer
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up to 12 weeks
|
Quality of Life Health Survey
Time Frame: up to 12 weeks
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Change in quality of life metrics as measured by SF-36 Health Survey
|
up to 12 weeks
|
Quality of Life-Pain
Time Frame: up to 12 weeks
|
Change in quality of life metrics as measured by changes in the patients reported pain scores as measure by the Visual Analog Scale
|
up to 12 weeks
|
Cost effectiveness of treatment
Time Frame: up to 12 weeks
|
Cost effectiveness of treatment regime.
looking at the number of grafts used on each study subject throughout the study.
|
up to 12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: William Tettelbach, MD, Intermountain Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ECDFU001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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