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

NCT01693133 | Completed DMC

• 1 other identifier: EFDFU003
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 20

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.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects with complete closure of the study ulcer

  Assessed by the Investigator, during treatment (Visits 1 - 13).

  Week 12

Secondary Outcomes (5)

• Time to complete closure for both groups

  Up to 12 Weeks

• Rate of wound closure

  Up to Week 12

• Incidence of ulcer recurrence

  Up to Week 16

• Quality of Life

  Up to Week 12

• Cost effectiveness of treatment

  Up to Week 12

Other Outcomes (1)

• Safety

  Up to Week 16

Study Arms (2)

Control

OTHER

Standard of Care: Moist Wound Therapy and Offloading

Other: Standard of Care: Moist Wound Therapy and Offloading

EpiFix plus Standard of Care

EXPERIMENTAL

Weekly application of EpiFix (up to 12 week) and standard of care (moist wound therapy and offloading)

Other: EpiFix plus Standard of Care

Interventions

Standard of Care: Moist Wound Therapy and Offloading OTHER

Standard of Care: Moist Wound Therapy and Offloading

Control

EpiFix plus Standard of Care OTHER

Weekly application of EpiFix and Standard of Care

EpiFix plus Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female age 18 or older.
• The patient is willing and able to provide informed consent and participate in all procedures and follow up evaluations necessary to complete the study.
• 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.
• Wounds should be diabetic foot ulcers located on the dorsal or plantar surface of the foot.
• Patients with Type 1 or 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
• 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).
• Affected leg has been offloaded (removable walker or total contact cast) for \>14 consecutive days prior to randomization.
• Serum Creatinine less than 3.0mg/dl (within last 6 months).
• HbA1c less than 12% within previous 60 days.
• 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.
• Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).

You may not qualify if:

• 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.
• Patients with multiple wounds on the same foot where other wounds are within 3 cm of the wound under care.
• Patients considered not in reasonable metabolic control, confirmed by an HbA1c 12% or greater at any time within previous 60 days.
• Known history of poor compliance with medical treatments.
• Patients currently enrolled in this study. Concurrent enrollment in the study is prohibited.
• Patients treated with investigational drug(s) or therapeutic device(s) within 30 days.
• Patients currently receiving radiation therapy or chemotherapy.
• Known or suspected local skin malignancy to the index diabetic ulcer.
• Patients diagnosed with autoimmune connective tissue diseases.
• Non-revascularizable surgical sites.
• Active infection at index site or currently being treated with antibiotics
• Any pathology that would limit the blood supply and compromise healing.
• 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.
• Patients who are known to be pregnant, plan to become pregnant, or are breast feeding.
• Known allergy to Gentamicin sulfate or Streptomycin sulfate.

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (20)

Central Research Associates, Inc.

Birmingham, Alabama, 35205, United States

Location

Stockdale Podiatry Group

Bakersfield, California, 93309, United States

Location

Center for Clinical Research Inc

Castro Valley, California, 94546, United States

Location

Valley Vascular Surgery Associates

Fresno, California, 93720, United States

Location

Limb Preservation Platform

Fresno, California, 93721, United States

Location

Novak Urgent Care and Family Practice

Indio, California, 92201, United States

Location

Loma Linda VA Medical Center

Loma Linda, California, 92357, United States

Location

Foot & Ankle Clinic

Los Angeles, California, 90057, United States

Location

Palmtree Clinical Research, Inc.

Palm Springs, California, 92262, United States

Location

Center for Clinical Research, Inc.

Sacramento, California, 95628, United States

Location

Center for Clinical Research

San Francisco, California, 94115, United States

Location

MetroWest Medical Center

Framingham, Massachusetts, 01702, United States

Location

South Shore Hospital

Weymouth, Massachusetts, 02190, United States

Location

Jobst Vascular Institute, Promedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Center for Clinical Research, Inc.

Eugene, Oregon, 97401, United States

Location

Dorn VA

Columbia, South Carolina, 29209, United States

Location

Futuro Clinical Trials, LLC

McAllen, Texas, 78501, United States

Location

IMC Wound Care

Murray, Utah, 84157, United States

Location

LDS Hospital

Salt Lake City, Utah, 84143, United States

Location

Coastal Podiatry, Inc.

Virginia Beach, Virginia, 23464, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• William Tettelbach, MD

  Intermountain Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 26, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: September 24, 2018

Record last verified: 2018-09

Locations

US (20)