5-Year Follow-Up of Advanced Therapy Use in High-Risk Diabetic Foot Ulcers
Background/Objectives: Advanced wound healing biologics for diabetic foot ulcer (DFU) are typically withheld from persons who are at high risk for amputation. However, a prospective, single-center cohort study evaluated the use of an advanced biologic, dehydrated amniotic (DAMA) tissue as early trea...
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MDPI AG
2025-07-01
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| Series: | Diabetology |
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| Online Access: | https://www.mdpi.com/2673-4540/6/7/61 |
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| author | Margaret Doucette Stephanie Seabolt Kattie Payne Jeremy Boyd |
| author_facet | Margaret Doucette Stephanie Seabolt Kattie Payne Jeremy Boyd |
| author_sort | Margaret Doucette |
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| description | Background/Objectives: Advanced wound healing biologics for diabetic foot ulcer (DFU) are typically withheld from persons who are at high risk for amputation. However, a prospective, single-center cohort study evaluated the use of an advanced biologic, dehydrated amniotic (DAMA) tissue as early treatment for DFUs in patients with a high risk for amputation, demonstrating benefit for a small sample. This is the report of the five-year follow-up of those high-risk participants. Methods: This chart review provides a 5-year follow-up of 18 of 20 participants in the original study. The data were collected by medical record review. Specific data points included mortality, re-ulceration and additional ulceration, amputation (minor and major), end-stage renal disease with dialysis dependence, hospitalization, and limb-threatening ischemia. Results: The 5-year mortality rate from the time of wound healing was 50% (9/18 deceased). Four of the eighteen participants (22.2%) underwent major amputation within 5 years of study completion. Two had amputations of the study limb and two had amputations of the contralateral limb. Fifty percent (2/4) of those who had amputations died within 5 years after the major amputation. Over fifty percent (55.5% or 10 out of 18) of the participants experienced the re-ulceration of the original study ulcer and 94% (17 out of 18) developed a new site ulceration. A total of 25% of the hospitalizations over the 5 years were related to DFU (infection, osteomyelitis, and sepsis). Conclusions: This small-sample 5-year follow-up shows that early treatment with dehydrated amniotic (DAMA) tissue in patients with diabetic foot ulcers of moderate-to-high amputation risk results in similar outcomes as noted in the current research on patients with low risk for amputation. In fact, this paper may suggest that advanced biologics can safely be used for early treatment in moderate-to-high amputation risk without increasing mortality and amputation over 5 years. |
| format | Article |
| id | doaj-art-9d460d7c9ffa4aa7be793ff749658d3f |
| institution | Kabale University |
| issn | 2673-4540 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diabetology |
| spelling | doaj-art-9d460d7c9ffa4aa7be793ff749658d3f2025-08-20T03:32:31ZengMDPI AGDiabetology2673-45402025-07-01676110.3390/diabetology60700615-Year Follow-Up of Advanced Therapy Use in High-Risk Diabetic Foot UlcersMargaret Doucette0Stephanie Seabolt1Kattie Payne2Jeremy Boyd3Boise VA Medical Center, Boise, ID 83702, USABoise VA Medical Center, Boise, ID 83702, USABoise VA Medical Center, Boise, ID 83702, USABoise VA Medical Center, Boise, ID 83702, USABackground/Objectives: Advanced wound healing biologics for diabetic foot ulcer (DFU) are typically withheld from persons who are at high risk for amputation. However, a prospective, single-center cohort study evaluated the use of an advanced biologic, dehydrated amniotic (DAMA) tissue as early treatment for DFUs in patients with a high risk for amputation, demonstrating benefit for a small sample. This is the report of the five-year follow-up of those high-risk participants. Methods: This chart review provides a 5-year follow-up of 18 of 20 participants in the original study. The data were collected by medical record review. Specific data points included mortality, re-ulceration and additional ulceration, amputation (minor and major), end-stage renal disease with dialysis dependence, hospitalization, and limb-threatening ischemia. Results: The 5-year mortality rate from the time of wound healing was 50% (9/18 deceased). Four of the eighteen participants (22.2%) underwent major amputation within 5 years of study completion. Two had amputations of the study limb and two had amputations of the contralateral limb. Fifty percent (2/4) of those who had amputations died within 5 years after the major amputation. Over fifty percent (55.5% or 10 out of 18) of the participants experienced the re-ulceration of the original study ulcer and 94% (17 out of 18) developed a new site ulceration. A total of 25% of the hospitalizations over the 5 years were related to DFU (infection, osteomyelitis, and sepsis). Conclusions: This small-sample 5-year follow-up shows that early treatment with dehydrated amniotic (DAMA) tissue in patients with diabetic foot ulcers of moderate-to-high amputation risk results in similar outcomes as noted in the current research on patients with low risk for amputation. In fact, this paper may suggest that advanced biologics can safely be used for early treatment in moderate-to-high amputation risk without increasing mortality and amputation over 5 years.https://www.mdpi.com/2673-4540/6/7/61diabetic footdiabetic neuropathies5-year follow-upamputationmortalityhospitalizations |
| spellingShingle | Margaret Doucette Stephanie Seabolt Kattie Payne Jeremy Boyd 5-Year Follow-Up of Advanced Therapy Use in High-Risk Diabetic Foot Ulcers Diabetology diabetic foot diabetic neuropathies 5-year follow-up amputation mortality hospitalizations |
| title | 5-Year Follow-Up of Advanced Therapy Use in High-Risk Diabetic Foot Ulcers |
| title_full | 5-Year Follow-Up of Advanced Therapy Use in High-Risk Diabetic Foot Ulcers |
| title_fullStr | 5-Year Follow-Up of Advanced Therapy Use in High-Risk Diabetic Foot Ulcers |
| title_full_unstemmed | 5-Year Follow-Up of Advanced Therapy Use in High-Risk Diabetic Foot Ulcers |
| title_short | 5-Year Follow-Up of Advanced Therapy Use in High-Risk Diabetic Foot Ulcers |
| title_sort | 5 year follow up of advanced therapy use in high risk diabetic foot ulcers |
| topic | diabetic foot diabetic neuropathies 5-year follow-up amputation mortality hospitalizations |
| url | https://www.mdpi.com/2673-4540/6/7/61 |
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