Trial of Dehydrated Human Amnion/Chorion Membrane (dHACM) In the Management of Diabetic Foot Ulcers
Information source: MiMedx Group, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Foot Ulcer
Intervention: Standard of Care: Moist Wound Therapy and Offloading (Other); EpiFix plus Standard of Care (Other)
Phase: N/A
Status: Recruiting
Sponsored by: MiMedx Group, Inc. Official(s) and/or principal investigator(s): William Tettelbach, MD, Principal Investigator, Affiliation: Intermountain Medical Center
Overall contact: William Tettlebach, MD, Phone: 801-507-9310, Email: bill.tettelbach@imail.org
Summary
The objective of this study is to evaluate the percentage of patients with complete diabetic
foot ulcer (DFU) closure following up to 12 weeks of treatment with either dehydrated human
amnion/chorion membrane (dHACM) plus standard of care (SOC) or SOC alone.
Clinical Details
Official title: A Multicenter, Prospective, Randomized, Controlled, Comparative Parallel Study of Dehydrated Human Amnion/Chorion Membrane (dHACM) Wound Graft in the Management of Diabetic Foot Ulcers
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of subjects with complete closure of the study ulcer
Secondary outcome: Time to complete closure for both groupsRate of wound closure Incidence of ulcer recurrence Quality of Life Cost effectiveness of treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Male or female age 18 or older.
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 (≤20% 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:
1. Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive
probe-tobone will be confirmed when bone or joint can be felt with a sterile,
ophthalmological probe.
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.
Locations and Contacts
William Tettlebach, MD, Phone: 801-507-9310, Email: bill.tettelbach@imail.org
Valley Vascular Surgery Associates, Fresno, California 93720, United States; Recruiting Brienne Doan, Phone: 925-858-0714 Shawn Cazzell, DPM, Principal Investigator
Novak Urgent Care and Family Practice, Indio, California 92201, United States; Recruiting Carlos Martinez, MD, Phone: 760-799-8890, Email: cmartinez@palmtreeclinical.com Steve Novak, MD, Principal Investigator
Center for Clinical Research, San Francisco, California 94115, United States; Recruiting Melissa Krueger, Phone: 800-636-1069 Alexander Reyzelman, DPM, Principal Investigator
MetroWest Medical Center, Framingham, Massachusetts 01702, United States; Completed
South Shore Hospital, Weymouth, Massachusetts 02190, United States; Not yet recruiting Cynthia Hernan, Phone: 781-624-4950 Gary Gibbons, MD, Principal Investigator
Jobst Vascular Institute, Promedica Toledo Hospital, Toledo, Ohio 43606, United States; Recruiting Joan Bick, RN, MSN, Phone: 419-291-7182, Email: Joan.Bick@ProMedica.org Steven Gale, MD, Principal Investigator
IMC Wound Care, Murray, Utah 84157, United States; Recruiting William Tettelbach, MD, Phone: 801-507-9310 William Tettelbach, MD, Principal Investigator
LDS Hospital, Salt Lake City, Utah 84143, United States; Recruiting William Tettelbach, MD, Phone: 801-408-3638 William Tettelbach, MD, Principal Investigator
Additional Information
Starting date: July 2012
Last updated: March 16, 2015
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