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Trial of Dehydrated Human Amnion/Chorion Membrane (dHACM) In the Management of Diabetic Foot Ulcers

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by MiMedx Group, Inc.
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.
ClinicalTrials.gov Identifier:
NCT01693133
First received: September 19, 2012
Last updated: November 20, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Diabetic Foot Ulcer
Other: Standard of Care: Moist Wound Therapy and Offloading
Other: EpiFix plus Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by MiMedx Group, Inc.:

Primary Outcome Measures:
  • Percentage of subjects with complete closure of the study ulcer [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Assessed by the Investigator, during treatment (Visits 1 - 13).


Secondary Outcome Measures:
  • Time to complete closure for both groups [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: No ]
    As assessed by photographic evaluation and the Investigator

  • Rate of wound closure [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
    As assessed by photographic evaluation and the Investigator

  • Incidence of ulcer recurrence [ Time Frame: Up to Week 16 ] [ Designated as safety issue: No ]
    Incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.

  • Quality of Life [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
    Change in quality of life metrics as measured by SF-36 Health Survey and changes in the patient's reported pain scores as measured by the Visual Analog Scale.

  • Cost effectiveness of treatment [ Time Frame: Up to Week 12 ] [ Designated as safety issue: No ]
    Cost effectiveness of treatment regimen.


Other Outcome Measures:
  • Safety [ Time Frame: Up to Week 16 ] [ Designated as safety issue: Yes ]
    The Safety population will be used for the analysis of safety endpoints.


Estimated Enrollment: 84
Study Start Date: July 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control
Standard of Care: Moist Wound Therapy and Offloading
Other: Standard of Care: Moist Wound Therapy and Offloading
Standard of Care: Moist Wound Therapy and Offloading
Experimental: EpiFix plus Standard of Care
Weekly application of EpiFix (up to 12 week) and standard of care (moist wound therapy and offloading)
Other: EpiFix plus Standard of Care
Weekly application of EpiFix and Standard of Care

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01693133

Contacts
Contact: William Tettlebach, MD 801-507-9310 bill.tettelbach@imail.org

Locations
United States, California
Valley Vascular Surgery Associates Recruiting
Fresno, California, United States, 93720
Contact: Brienne Doan    925-858-0714      
Principal Investigator: Shawn Cazzell, DPM         
Novak Urgent Care and Family Practice Recruiting
Indio, California, United States, 92201
Contact: Carlos Martinez, MD    760-799-8890    cmartinez@palmtreeclinical.com   
Principal Investigator: Steve Novak, MD         
Center for Clinical Research Recruiting
San Francisco, California, United States, 94115
Contact: Melissa Krueger    800-636-1069      
Principal Investigator: Alexander Reyzelman, DPM         
United States, Massachusetts
MetroWest Medical Center Completed
Framingham, Massachusetts, United States, 01702
South Shore Hospital Not yet recruiting
Weymouth, Massachusetts, United States, 02190
Contact: Cynthia Hernan    781-624-4950      
Principal Investigator: Gary Gibbons, MD         
United States, Ohio
Jobst Vascular Institute, Promedica Toledo Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Joan Bick, RN, MSN    419-291-7182    Joan.Bick@ProMedica.org   
Principal Investigator: Steven Gale, MD         
United States, Utah
IMC Wound Care Recruiting
Murray, Utah, United States, 84157
Contact: William Tettelbach, MD    801-507-9310      
Principal Investigator: William Tettelbach, MD         
LDS Hospital Recruiting
Salt Lake City, Utah, United States, 84143
Contact: William Tettelbach, MD    801-408-3638      
Principal Investigator: William Tettelbach, MD         
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
Principal Investigator: William Tettelbach, MD Intermountain Medical Center
  More Information

No publications provided

Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT01693133     History of Changes
Other Study ID Numbers: EFDFU003
Study First Received: September 19, 2012
Last Updated: November 20, 2014
Health Authority: United States: Institutional Review Board

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 November 25, 2014