Study of Amniotic Membrane Graft in the Management of Diabetic Foot Ulcers

A Prospective, Randomized, Comparative Parallel Study of Amniotic Membrane Graft in the Management of Diabetic Foot Ulcers

This is comparison trial comparing human amniotic membrane to standard wound care for non healing diabetic foot wounds over a 12 weeks period

Study Overview

• Status: Unknown
• Conditions: Diabetic Foot; Foot Ulcer; Diabetic
• Intervention / Treatment: Device: Offloading; Procedure: Dressing Application

Detailed Description

This is a prospective, stratified, randomized, comparative, parallel group, Multi-center clinical trial comparing the proportion of ulcers completely healed by use of amniotic membrane graft (Amnioband)versus the standard protocol of wound care in diabetic patients with a diabetic foot ulcer with adequate arterial perfusion, for wound healing to the affected limb. The investigators will compare the proportion of ulcers completely healed by the amniotic membrane graft protocol of care to the standard protocol of care in the management of indolent diabetic ulcers at 6 weeks. In addition the investigators will compare the proportion of healing at 4 weeks, 12 weeks and, the mean time to healing, and the cost effectiveness of the two protocols of care. Mean time to healing will be measured by wound tracings.

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

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Canfield, Ohio, United States, 44406
      • Recruiting
      • Lower Extremity Institute of Research and Therapy
      • Contact: Maura Maloney, JD; Phone Number: 3307160203
      • Contact: Lawrence Didomenico, DPM; Phone Number: 330-727-4148
      • Principal Investigator: Lawrence DiDomenico, DPM
  • Virginia
    • Danville, Virginia, United States, 24112
      • Recruiting
      • Martinsville Research Institute
      • Contact: Nathan Young, DPM; Phone Number: 540-676-5886
      • Contact: Kimberly Young; Phone Number: (540) 676-5886
      • Principal Investigator: Nathan Young, DPM
    • Troutville, Virginia, United States, 24019
      • Recruiting
      • Shenandoah Lower Extremity Research Institute
      • Contact: Jennifer Keller, DPM; Phone Number: 540-529-6155
      • Contact: Hillary Dillow; Phone Number: 540-904-1458
      • Principal Investigator: Jennifer Keller, DPM

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. Patients age 18 or older.
2. Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
3. Patient's ulcer must be diabetic in origin and larger than 1 cm2.
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 conventional ulcer therapy to heal the wound.
6. A two week run-in period will precede enrollment/ randomization in the trial to document the indolent nature of the wounds selected.
7. Additional wounds may be present but not within 3 cm of the study wound.
8. Wound must be present anatomically on the foot as defined by beginning below the malleoli of the ankle and be neuropathic in origin.
9. Patient's ulcer must exhibit no clinical signs of infection.
10. Serum Creatinine less than 3.0mg/dl within last six months.
11. HbA1c less than or equal to 12% within last 90 days.

12. 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,
    • 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 tendon, muscle, capsule or 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 25 cm2.
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 within the last six months.
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. Patients who are pregnant or breast feeding.
15. Patients who are taking medications that are considered immune system modulators which could affect graft incorporation.
16. Patients with known hypersensitivity to components of any treatment used in the trial.
17. Wounds greater than one year in duration without intermittent healing.
18. Wounds improving greater than 20% over the first two weeks (run-in period) of the trial using standard of care dressing and camboot.
19. Patients taking Cox-2 inhibitors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard of Care; Surgical debridement of diabetic foot ulcer, followed by collagen alginate and gauze dressing application to be changed daily by patient. Patient will practice offloading, reassessment weekly at office visit	Device: Offloading; Provision of an offloading cam walker or cast boot, may also convert to "total contact cast" and add felt or foam to supplement
Experimental: Amniotic Membrane / Amnioband; Application of Amnioband with dressing application, to be changed weekly following surgical debridement. Patient will practice offloading. If the ulcer is not closed completely Amnioband will be applied weekly at weeks 2-11	Device: Offloading; Provision of an offloading cam walker or cast boot, may also convert to "total contact cast" and add felt or foam to supplement; Procedure: Dressing Application; Application of a non adherent dressing, and a multi-layer compression dressing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of ulcers completely healed by amniotic memrane versus standard care	The primary objective of this study is to compare the proportion of ulcers completely healed by the amniotic membrane graft protocol of care to the standard protocol of care in the management of indolent diabetic ulcers at 6 weeks	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of ulcers healed by amniotic membrane versus standard care	The secondary objectives of this study are to compare the proportion of healing at 12 weeks	12 weeks

Collaborators and Investigators

• Sponsor: Lower Extremity Institute for Research and Therapy
• Collaborators: Musculoskeletal Transplant Foundation
• Investigators: Principal Investigator: Lawrence Didomenico, DPM, Medical Director

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: March 23, 2015
• First Submitted That Met QC Criteria: March 25, 2015
• First Posted (Estimate): March 26, 2015

Study Record Updates

• Last Update Posted (Estimate): August 16, 2016
• Last Update Submitted That Met QC Criteria: August 14, 2016
• Last Verified: August 1, 2016

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: 001 (NavyGHB)