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

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02399826
• Other study ID #: 001
• Status: Recruiting
• Phase: N/A
• First received: March 23, 2015
• Last updated: August 14, 2016
• Start date: March 2015

Study information

• Verified date: August 2016
• Source: Lower Extremity Institute for Research and Therapy
• Contact: Lawrence Didomenico, DPM
• Phone: 3307274148
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Lower Extremity Institute of Research and Therapy	Canfield	Ohio
United States	Martinsville Research Institute	Danville	Virginia
United States	Shenandoah Lower Extremity Research Institute	Troutville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Lower Extremity Institute for Research and Therapy	Musculoskeletal Transplant Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No