Prevention of Amputation in Diabetic Foot Ulcers Using Amniotic Tissue
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02632929|
Recruitment Status : Active, not recruiting
First Posted : December 17, 2015
Last Update Posted : July 16, 2019
|Condition or disease|
|Diabetic Foot Ulcer|
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||Prevention of Amputation in a High Risk Population With Comprehensive Care and Amniotic Tissue|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 2019|
Diabetic Foot Ulcers at Amputation Risk
Patients at high risk for limb amputation from a diabetic foot ulcer will be treated with comprehensive, interdisciplinary approach (usual care) in combination with early application of advanced therapy; dehydrated human amniotic membrane allografts (AMNIOEXCEL®, Derma Science, Princeton, New Jersey).
- Limb salvage [ Time Frame: One month past wound healing ]All subjects will be seen weekly/biweekly by the study team until the point of definitive wound closure (epithelialization) and the subject has the ability to progress weight bearing and ambulation.
- effective wound healing [ Time Frame: One month past wound healing ]Early application of amniotic tissue and multidisciplinary team comprehensive care on diabetic foot ulcers with a high risk for amputation
- Diabetic Foot Ulcer Quality of life Short Form survey [ Time Frame: Comparison of patient's perception at enrollment, wound heal, one month, and 2-4 months after the wound is healed. ]Quality of life measured at enrollment in study, at wound healed, one month post-healed, and 2-4 months later.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02632929
|United States, Idaho|
|Boise, Idaho, United States, 83702|
|Principal Investigator:||Margaret Doucette, D. O.||Boise VAMC|
|Study Director:||Kattie B Payne, PhD, RN, MSN||Boise VAMC|