Diabetic Foot UlcerNCT02632929
Prevention of Amputation in Diabetic Foot Ulcers Using Amniotic Tissue
An observational study of Diabetic Foot Ulcer, run by Boise VA Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2015to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Amputation in a High Risk Population With Comprehensive Care and Amniotic Tissue
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).
Read the 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.
- Conditions
- Diabetic Foot Ulcer
- Keywords
- foot ulcer, diabetic, wound healing, diabetic foot ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Limb salvage
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.
Measured: One month past wound healing
Secondary outcomes (1)
effective wound healing
Early application of amniotic tissue and multidisciplinary team comprehensive care on diabetic foot ulcers with a high risk for amputation
Measured: One month past wound healing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start30 May 2015
- Primary completion31 Aug 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boise VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Integra LifeSciences Corporation
- Responsible party
- Principal investigator, Margaret Doucette, Boise VA Medical Center
- Investigators
- Margaret Doucette, D. O., Principal investigator, Boise VAMCKattie B Payne, PhD, RN, MSN, Study director, Boise VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632929
- Sponsor's protocol ID
- 00816
- Status last verified
- Jul 2023
- First submitted
- 14 Dec 2015
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: This is a pilot study.
Publications
Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.
PubMed 24126108Abetz, L., Sutton, M., Brady, L., McNulty, P., Gagnon, D. The Diabetic Foot Ulcer Scale (DFS): a quality of life instrument for use in clinical trials. Pract Diab Int July/August 2002 Vol 19 No. 6
Bann CM, Fehnel SE, Gagnon DD. Development and validation of the Diabetic Foot Ulcer Scale-short form (DFS-SF). Pharmacoeconomics. 2003;21(17):1277-90. doi: 10.2165/00019053-200321170-00004.
PubMed 14986739Doucette M, Payne KM, Lough W, Beck A, Wayment K, Huffman J, Bond L, Thomas-Vogel A, Langley S. Early Advanced Therapy for Diabetic Foot Ulcers in High Amputation Risk Veterans: A Cohort Study. Int J Low Extrem Wounds. 2022 Jun;21(2):111-119. doi: 10.1177/1534734620928151. Epub 2020 Jun 22.
PubMed 32567415
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Amputation in a High Risk Population With Comprehensive Care and Amniotic Tissue
- ClinicalTrials.gov ID
- NCT02632929
- Acronym / sponsor ID
- 00816
- Conditions
- Diabetic Foot Ulcer
- Keywords
- foot ulcer, diabetic, wound healing, diabetic foot ulcer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Boise VA Medical CenterUS federal agency
- Collaborators
- Integra LifeSciences Corporation
- Study start
- 30 May 2015
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
effective wound healing
Time frame: One month past wound healing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 24126108Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.
- BackgroundAbetz, L., Sutton, M., Brady, L., McNulty, P., Gagnon, D. The Diabetic Foot Ulcer Scale (DFS): a quality of life instrument for use in clinical trials. Pract Diab Int July/August 2002 Vol 19 No. 6
- Background: PubMed 14986739Bann CM, Fehnel SE, Gagnon DD. Development and validation of the Diabetic Foot Ulcer Scale-short form (DFS-SF). Pharmacoeconomics. 2003;21(17):1277-90. doi: 10.2165/00019053-200321170-00004.
- Derived from this study: PubMed 32567415Doucette M, Payne KM, Lough W, Beck A, Wayment K, Huffman J, Bond L, Thomas-Vogel A, Langley S. Early Advanced Therapy for Diabetic Foot Ulcers in High Amputation Risk Veterans: A Cohort Study. Int J Low Extrem Wounds. 2022 Jun;21(2):111-119. doi: 10.1177/1534734620928151. Epub 2020 Jun 22.
- Individual participant dataSharing planned: No. This is a pilot study.
Related trials for Diabetic Foot Ulcer
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Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Doucette, D. O. principal investigator
Boise VAMC
Kattie B Payne, PhD, RN, MSN study director
Boise VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer, run by Boise VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limb salvage (time frame: One month past wound healing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02632929, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.