Clinical trial NCT01693133: Trial of Dehydrated Human Amnion/Chorion Membrane (dHACM) In the Management of Diabetic Foot Ulcers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Lead sponsor: MiMedx Group, Inc.
Sponsor class: INDUSTRY
First posted: 2012-09-26
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of subjects with complete closure of the study ulcer
timeFrame: Week 12
Secondary outcomes:
measure: Time to complete closure for both groups
timeFrame: Up to 12 Weeks
measure: Rate of wound closure
timeFrame: Up to Week 12
measure: Incidence of ulcer recurrence
timeFrame: Up to Week 16
measure: Quality of Life
timeFrame: Up to Week 12
measure: Cost effectiveness of treatment
timeFrame: Up to Week 12
Other outcomes:
measure: Safety
timeFrame: Up to Week 16
Locations:
city: Birmingham
country: United States
facility: Central Research Associates, Inc.
state: Alabama
city: Bakersfield
country: United States
facility: Stockdale Podiatry Group
state: California
city: Castro Valley
country: United States
facility: Center for Clinical Research Inc
state: California
city: Fresno
country: United States
facility: Valley Vascular Surgery Associates
state: California
city: Fresno
country: United States
facility: Limb Preservation Platform
state: California
city: Indio
country: United States
facility: Novak Urgent Care and Family Practice
state: California
city: Loma Linda
country: United States
facility: Loma Linda VA Medical Center
state: California
city: Los Angeles
country: United States
facility: Foot & Ankle Clinic
state: California
city: Palm Springs
country: United States
facility: Palmtree Clinical Research, Inc.
state: California
city: Sacramento
country: United States
facility: Center for Clinical Research, Inc.
state: California
city: San Francisco
country: United States
facility: Center for Clinical Research
state: California
city: Framingham
country: United States
facility: MetroWest Medical Center
state: Massachusetts
city: Weymouth
country: United States
facility: South Shore Hospital
state: Massachusetts
city: Toledo
country: United States
facility: Jobst Vascular Institute, Promedica Toledo Hospital
state: Ohio
city: Eugene
country: United States
facility: Center for Clinical Research, Inc.
state: Oregon
city: Columbia
country: United States
facility: Dorn VA
state: South Carolina
city: McAllen
country: United States
facility: Futuro Clinical Trials, LLC
state: Texas
city: Murray
country: United States
facility: IMC Wound Care
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Virginia Beach
country: United States
facility: Coastal Podiatry, Inc.
state: Virginia
Study officials:
affiliation: Intermountain Medical Center
name: William Tettelbach, MD
role: PRINCIPAL_INVESTIGATOR
References: