Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers

A Prospective, Randomized, Comparative Study of Amniotic Membrane Wound Graft With Weekly Versus BiWeekly Application In the Management of Diabetic Foot Ulcers

The purpose of this study is to determine whether a weekly application of EpiFix human amniotic membrane is more effective than a biweekly application (every two weeks) in the treatment of diabetic foot ulcers.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Other: Weekly application of EpiFix plus standard of care; Other: Biweekly application of EpiFix plus standard of care

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24016
      • Professional Education and Research Institute
    • Salem, Virginia, United States, 24153
      • Professional Education and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female age 18 or older
2. Informed consent must be obtained
3. Patient's ulcer must be diabetic in origin and larger than 1cm2. Debridement will be done prior to randomization. Subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement.
4. Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
5. Ulcer must be present for a minimum of four weeks before enrollment/randomization, with documented failure of prior treatment to heal the wound. A two week run in period will precede enrollment/randomization in the trial to document the indolent nature of the wounds selected
6. Additional wounds may be present but not within 3cm of the study wound
7. Wound must be present anatomically on the plantar surface of the foot
8. Patient's ulcer must exhibit no clinical signs of infection.
9. Patient is of legal consenting age.
10. Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
11. Serum Creatine less then 3.0mg/dl
12. HbA1c less than 12%

13. 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 leg

Exclusion Criteria:

1. Patients presenting with an ulcer probing to bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
2. Patients whose index diabetic foot ulcers are greater than 25cm2.
3. Patients considered not in reasonable metabolic control, confirmed by an HbA1c greater than 12% within previous 90 days,
4. Patients whose serum creatinine levels are 3.0mg/dl or greater.
5. Patients with a known history of poor compliance with medical treatments.
6. Patients who have been previously randomized into this study, or are presently participating in another clinical trial
7. Patients who are currently receiving radiation therapy or chemotherapy.
8. Patients with known or suspected local skin malignancy to the index diabetic ulcer.
9. Patients diagnosed with autoimmune connective tissues diseases.
10. Non-revascularizable surgical sites
11. Active infection at site
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
14. Patient who are pregnant or breast feeding
15. Patient who are taking medications that are considered immune system modulator which could affect graft incorporation.
16. Allergy to Gentamycin or Streptomycin
17. Wounds greater than one year in duration without intermittent healing
18. Wound improving greater than 20% over the first two weeks of the trial using standard of care dressing and Cam Boot

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Weekly Application of EpiFix; Weekly application of EpiFix plus standard of care	Other: Weekly application of EpiFix plus standard of care
EXPERIMENTAL: Biweekly application of EpiFix; Biweekly application of EpiFix plus standard of care	Other: Biweekly application of EpiFix plus standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean time to healing	up to 12 Week

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of completely healed ulcers	Week 4 and Week 12
Percent change in wound area	Week 4 and Week 12

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: August 2, 2012
• First Submitted That Met QC Criteria: August 2, 2012
• First Posted (ESTIMATE): August 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): December 11, 2013
• Last Update Submitted That Met QC Criteria: December 10, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: EFDFU002