Trial of Dehydrated Human Amnion/Chorion Membrane (dHACM) In the Management of Diabetic Foot Ulcers
NCT ID: NCT01693133
Last Updated: 2018-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
132 participants
INTERVENTIONAL
2012-07-31
2018-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds
NCT06236750
DHACM vs Other Commercially Available Treatments
NCT01921491
Use of dHACM in the Treatment of Venous Leg Ulcers
NCT02011503
dHACM In the Treatment of Diabetic Foot Ulcers
NCT02587104
dHACM Mesh In the Treatment of Diabetic Foot Ulcers
NCT02589210
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Standard of Care: Moist Wound Therapy and Offloading
Standard of Care: Moist Wound Therapy and Offloading
Standard of Care: Moist Wound Therapy and Offloading
EpiFix plus Standard of Care
Weekly application of EpiFix (up to 12 week) and standard of care (moist wound therapy and offloading)
EpiFix plus Standard of Care
Weekly application of EpiFix and Standard of Care
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Standard of Care: Moist Wound Therapy and Offloading
Standard of Care: Moist Wound Therapy and Offloading
EpiFix plus Standard of Care
Weekly application of EpiFix and Standard of Care
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. The patient is willing and able to provide informed consent and participate in all procedures and follow up evaluations necessary to complete the study.
3. Patient's ulcer must be diabetic in origin with a size ranging from 1 to 25 cm2. Debridement will be done prior to randomization, if clinically indicated.
4. Wounds should be diabetic foot ulcers located on the dorsal or plantar surface of the foot.
5. Patients with Type 1 or 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
6. Ulcer must be present for a minimum of 30 days before enrollment/randomization, with documented failure of prior treatment to heal the wound (≤25% wound area reduction after 14 consecutive days of therapy immediately prior to randomization when treated with standard protocol of care).
7. Affected leg has been offloaded (removable walker or total contact cast) for \>14 consecutive days prior to randomization.
8. Serum Creatinine less than 3.0mg/dl (within last 6 months).
9. HbA1c less than 12% within previous 60 days.
10. Patient 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 ≥30mmHg, OR
* ABIs with results of ≥0.7 and ≤1.2, OR
* Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected foot.
11. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
Exclusion Criteria
2. Patients with multiple wounds on the same foot where other wounds are within 3 cm of the wound under care.
3. Patients considered not in reasonable metabolic control, confirmed by an HbA1c 12% or greater at any time within previous 60 days.
4. Known history of poor compliance with medical treatments.
5. Patients currently enrolled in this study. Concurrent enrollment in the study is prohibited.
6. Patients treated with investigational drug(s) or therapeutic device(s) within 30 days.
7. Patients currently receiving radiation therapy or chemotherapy.
8. Known or suspected local skin malignancy to the index diabetic ulcer.
9. Patients diagnosed with autoimmune connective tissue diseases.
10. Non-revascularizable surgical sites.
11. Active infection at index site or currently being treated with antibiotics
12. Any pathology that would limit the blood supply and compromise healing.
13. Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days. Study ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days.
14. Patients who are known to be pregnant, plan to become pregnant, or are breast feeding.
15. Known allergy to Gentamicin sulfate or Streptomycin sulfate.
16. Active Charcot deformity or major structural abnormalities of the foot.
17. Wounds that are greater than one year in duration without intermittent closure.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MiMedx Group, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
William Tettelbach, MD
Role: PRINCIPAL_INVESTIGATOR
Intermountain Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Central Research Associates, Inc.
Birmingham, Alabama, United States
Stockdale Podiatry Group
Bakersfield, California, United States
Center for Clinical Research Inc
Castro Valley, California, United States
Valley Vascular Surgery Associates
Fresno, California, United States
Limb Preservation Platform
Fresno, California, United States
Novak Urgent Care and Family Practice
Indio, California, United States
Loma Linda VA Medical Center
Loma Linda, California, United States
Foot & Ankle Clinic
Los Angeles, California, United States
Palmtree Clinical Research, Inc.
Palm Springs, California, United States
Center for Clinical Research, Inc.
Sacramento, California, United States
Center for Clinical Research
San Francisco, California, United States
MetroWest Medical Center
Framingham, Massachusetts, United States
South Shore Hospital
Weymouth, Massachusetts, United States
Jobst Vascular Institute, Promedica Toledo Hospital
Toledo, Ohio, United States
Center for Clinical Research, Inc.
Eugene, Oregon, United States
Dorn VA
Columbia, South Carolina, United States
Futuro Clinical Trials, LLC
McAllen, Texas, United States
IMC Wound Care
Murray, Utah, United States
LDS Hospital
Salt Lake City, Utah, United States
Coastal Podiatry, Inc.
Virginia Beach, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EFDFU003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.