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

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693133
• Other study ID #: EFDFU003
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: June 2018

Study information

• Verified date: September 2018
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Other:
• Standard of Care: Moist Wound Therapy and Offloading
Standard of Care: Moist Wound Therapy and Offloading
• EpiFix plus Standard of Care
Weekly application of EpiFix and Standard of Care

Locations

Country	Name	City	State
United States	Stockdale Podiatry Group	Bakersfield	California
United States	Central Research Associates, Inc.	Birmingham	Alabama
United States	Center for Clinical Research Inc	Castro Valley	California
United States	Dorn VA	Columbia	South Carolina
United States	Center for Clinical Research, Inc.	Eugene	Oregon
United States	MetroWest Medical Center	Framingham	Massachusetts
United States	Limb Preservation Platform	Fresno	California
United States	Valley Vascular Surgery Associates	Fresno	California
United States	Novak Urgent Care and Family Practice	Indio	California
United States	Loma Linda VA Medical Center	Loma Linda	California
United States	Foot & Ankle Clinic	Los Angeles	California
United States	Futuro Clinical Trials, LLC	McAllen	Texas
United States	IMC Wound Care	Murray	Utah
United States	Palmtree Clinical Research, Inc.	Palm Springs	California
United States	Center for Clinical Research, Inc.	Sacramento	California
United States	LDS Hospital	Salt Lake City	Utah
United States	Center for Clinical Research	San Francisco	California
United States	Jobst Vascular Institute, Promedica Toledo Hospital	Toledo	Ohio
United States	Coastal Podiatry, Inc.	Virginia Beach	Virginia
United States	South Shore Hospital	Weymouth	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	The Safety population will be used for the analysis of safety endpoints.	Up to Week 16
Primary	Percentage of subjects with complete closure of the study ulcer	Assessed by the Investigator, during treatment (Visits 1 - 13).	Week 12
Secondary	Time to complete closure for both groups	As assessed by photographic evaluation and the Investigator	Up to 12 Weeks
Secondary	Rate of wound closure	As assessed by photographic evaluation and the Investigator	Up to Week 12
Secondary	Incidence of ulcer recurrence	Incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.	Up to Week 16
Secondary	Quality of Life	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.	Up to Week 12
Secondary	Cost effectiveness of treatment	Cost effectiveness of treatment regimen.	Up to Week 12