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Trial record 14 of 2645 for:    ( Map: Idaho, United States )

Prevention of Amputation in Diabetic Foot Ulcers Using Amniotic Tissue

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ClinicalTrials.gov Identifier: NCT02632929
Recruitment Status : Active, not recruiting
First Posted : December 17, 2015
Last Update Posted : July 16, 2019
Sponsor:
Collaborator:
Integra LifeSciences Corporation
Information provided by (Responsible Party):
Margaret Doucette, Boise VA Medical Center

Brief Summary:
The purpose of this study is to see whether the use of AMNIOEXCEL® improves healing and reduces the need to cut off all or part of a leg (amputation) in high-risk patients who have diabetes and foot sores (also sometimes called ulcers or wounds).

Condition or disease
Diabetic Foot Ulcer

Detailed Description:
The purpose of this study is to demonstrate the effectiveness of comprehensive, interdisciplinary approach (usual care) in combination with early application of advanced therapy; dehydrated human amniotic membrane allografts (AMNIOEXCEL®, Derma Science, Princeton, New Jersey) in healing and preventing amputation in high risk patients with diabetic foot ulcers.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
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).



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients with a diabetic foot ulcer referred to the High Risk Foot Clinic at Boise VAMC who meet the inclusion criteria, and are willing and able to participate will be enrolled.
Criteria

Inclusion Criteria:

  • Type 1 or 2 diabetes
  • Ulcer anywhere on the foot
  • Moderate to high risk for amputation according to Prevention of Amputation for Veterans Everywhere (PAVE) and the Society for Vascular Surgery Lower Extremity Threatened Limb (SVS WIfI) classification system (WIFi) criteria

Exclusion Criteria:

  • Inability or unwillingness to travel to Boise VA for clinic visits
  • Enrolled in Hospice
  • Have known or expected malignancy of foot ulcer
  • Are or planning to become pregnant
  • Signs of progressive gangrene, limb-threatening infection

Information from the National Library of Medicine

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


Locations
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United States, Idaho
Boise VAMC
Boise, Idaho, United States, 83702
Sponsors and Collaborators
Boise VA Medical Center
Integra LifeSciences Corporation
Investigators
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Principal Investigator: Margaret Doucette, D. O. Boise VAMC
Study Director: Kattie B Payne, PhD, RN, MSN Boise VAMC

Publications:
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Responsible Party: Margaret Doucette, Director, Physical Medicine and Rehabilitation, Boise VA Medical Center
ClinicalTrials.gov Identifier: NCT02632929     History of Changes
Other Study ID Numbers: 00816
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a pilot study.
Keywords provided by Margaret Doucette, Boise VA Medical Center:
foot ulcer, diabetic
wound healing
diabetic foot ulcer
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases