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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01693133
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : September 24, 2018
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Other: Standard of Care: Moist Wound Therapy and Offloading Other: EpiFix plus Standard of Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2012
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Percentage of subjects with complete closure of the study ulcer [ Time Frame: Week 12 ]
    Assessed by the Investigator, during treatment (Visits 1 - 13).


Secondary Outcome Measures :
  1. Time to complete closure for both groups [ Time Frame: Up to 12 Weeks ]
    As assessed by photographic evaluation and the Investigator

  2. Rate of wound closure [ Time Frame: Up to Week 12 ]
    As assessed by photographic evaluation and the Investigator

  3. Incidence of ulcer recurrence [ Time Frame: Up to Week 16 ]
    Incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.

  4. Quality of Life [ Time Frame: Up to Week 12 ]
    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.

  5. Cost effectiveness of treatment [ Time Frame: Up to Week 12 ]
    Cost effectiveness of treatment regimen.


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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 (≤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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01693133


Locations
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Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
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Principal Investigator: William Tettelbach, MD Intermountain Medical Center

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Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT01693133    
Other Study ID Numbers: EFDFU003
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: September 24, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases