Diabetic; Foot Ulcers Clinical Trial
Official title:
A Prospective, Randomized, Comparative Parallel Study of Allogenic Dermis Graft in the Management of Diabetic Foot Ulcers
| NCT number | NCT02331147 |
| Other study ID # | 20142081 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2014 |
| Est. completion date | March 2017 |
| Verified date | January 2018 |
| Source | Musculoskeletal Transplant Foundation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is comparison trial comparing human dermis to standard wound care for non healing diabetic wound
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | March 2017 |
| Est. primary completion date | March 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| 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: 1. Dorsum transcutaneous oxygen test (TcPO2) with results =30mmHg, 2. ABIs with results of =0.7 and =1.2, OR 3. 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Professional Education and Research Institute | Roanoke | Virginia |
| United States | Shenandoah Lower Extremity Research | Roanoke | Virginia |
| United States | Foot and Ankle Associates of Southwest VA | Salem | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| Musculoskeletal Transplant Foundation | Professional Education and Research Institute |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | proportion of ulcers completely healed by the allogenic dermal graft protocol of care to the standard protocol of care in the management of indolent diabetic ulcers at 6 weeks | 6 weeks | ||
| Secondary | Compare the proportion of ulcers completely healed at 4 weeks | 4 weeks | ||
| Secondary | Compare the proportion of ulcers completely healed at 12 weeks | 12 weeks | ||
| Secondary | Mean time to healing | 12 weeks |