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Tissue Augmentation with Allograft Adipose Matrix For the Diabetic Foot in Remission.

ABSTRACT: Repetitive stress on the neuropathic plantar foot is the primary cause of diabetic foot ulcers. After healing, recurrence is common. Modulating plantar pressure has been associated with extension of ulcer free days. Therefore, the goal of this study was to determine the effects of an injectable allograft adipose matrix in providing a protective padding and reducing the pressure in the plantar foot.After healing his recurrent ulcer using total contact casting, a 71-year-old man with a 9-year history of recurrent diabetic foot ulcers was treated with injection of allograft adipose matrix, procured from donated human tissue. This was delivered under postulcerative callus on the weight-bearing surface of the distal end of the first ray resection. As is standard in our clinic for tissue augmentation procedures, our patient underwent serial plantar pressure mapping using an in-shoe pressure monitoring system.There was a 76.8% decrease in the mean peak pressure due to the fat matrix injected into the second metatarsal region and a 70.1% decrease in mean peak pressure for the first ray resection at the site of the postulcerative callus. By 2 months postoperatively, there was no evidence of residual callus. This extended out to the end of clinical follow-up at 4 months.The results from this preliminary experience suggest that allograft adipose matrix delivered to the high risk diabetic foot may have promise in reducing tissue stress over pre- and postulcerative lesions. This may ultimately assist the clinician in extending ulcer-free days for patients in diabetic foot remission.

SUBMITTER: Shahin TB

PROVIDER: S-EPMC5682189 | biostudies-other | 2017 Oct

REPOSITORIES: biostudies-other

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Tissue Augmentation with Allograft Adipose Matrix For the Diabetic Foot in Remission.

Shahin Tala B TB Vaishnav Kairavi V KV Watchman Marcy M Subbian Vignesh V Larson Ethan E Chnari Evangelia E Armstrong David G DG

Plastic and reconstructive surgery. Global open 20171023 10

<h4>Background</h4>Repetitive stress on the neuropathic plantar foot is the primary cause of diabetic foot ulcers. After healing, recurrence is common. Modulating plantar pressure has been associated with extension of ulcer free days. Therefore, the goal of this study was to determine the effects of an injectable allograft adipose matrix in providing a protective padding and reducing the pressure in the plantar foot.<h4>Methods</h4>After healing his recurrent ulcer using total contact casting, a ...[more]

PMID: 29184753

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Project description:BackgroundThe "cancer analogy" is powerful for communicating risk to and organizing care for patients with diabetic foot syndrome. One potentially underappreciated similarity between cancer and foot ulcers is that both can recur at anatomical locations distinct from the primary occurrence, albeit with different physiological mechanisms. Few studies have characterized the location of diabetic foot ulcer recurrence, and these have been limited by considering only the first recurrent wound following a recent-healed wound. We therefore characterized the anatomical locations at which diabetic foot ulcers are likely to recur considering multiple wounds during follow-up and the locations of all prior wounds documented in the participant's history.MethodsWe completed a secondary analysis of existing data from a 129 participant multi-center study of participants in diabetic foot remission. The primary outcome was plantar foot ulceration, and each participant was followed for 34 weeks or until withdrawing consent, allowing characterization of all wounds occurring. We stratified the anatomical locations of wounds prior to the trial by the following outcome categories during the trial: no recurrence, recurrence to the same anatomical location, recurrence to a different anatomical location on the same foot, and recurrence to the contralateral foot.ResultsA large percentage (48%) of wounds recurred to the contralateral foot, and the proportion of subsequent foot ulcer to the contralateral limb was largely unaffected by the anatomical location of foot ulcer prior to the study. Only 17% of prior diabetic foot ulcers were followed by recurrence to the same anatomical location. Rates of recurrence remained high during treatment of a wound (0.41 foot ulcer/ulcer-year). Participants had documented wounds to 2.2 distinct anatomical locations on average, and more than 60% of participants had wounds to more than one plantar location by the end of the study.ConclusionsGiven the significant morbidity, mortality, and resource utilization associated with foot ulcer recidivism, quality and evidenced-based preventive care is essential. Our results better characterize the burden of recurrence and to what anatomy recurrence is most likely. These insights may benefit providers and patients alike for the provision of high-quality preventive care thereby resulting in reduced morbidity, mortality, and cost.Trial registrationThe study providing the data for this secondary analysis was registered on ClinicalTrials.gov (NCT02647346) on January 6, 2016. The study was retrospectively registered.

Project description:BACKGROUND:The diabetic foot ulcer (DFU) is one of the most prevalent complications of diabetes mellitus and often develops severe effects that can lead to amputation. A non-healing "minor" amputation often precedes a major amputation resulting in a negative impact on the function and quality of life of the patients. Stem cell-based therapies have emerged as a promising option to improve healing, and the adipose tissue is an abundant and easy to access source. The injection of autologous micro-fragmented adipose tissue at the amputation stump of a diabetic population undergoing a lower limb minor amputation was evaluated and compared with the standard care. METHODS:In this randomized controlled trial with two arms (parallel assignment) and no masking, 114 patients undergoing a lower limb minor amputation were randomized to standard of care or to micro-fragmented adipose tissue injection prepared using a minimal manipulation technique (Lipogems®) in a closed system. Clinical outcomes were determined monthly up to 6?months. Primary endpoint of the study was the evaluation of the healing rate and time after the minor amputation. Secondary endpoints included the assessment of safety, feasibility, technical success, relapse rate, skin tropism, and intensity of pain. RESULTS:At 6?months, 80% of the micro-fragmented adipose tissue-treated feet healed and 20% failed as compared with the control group where 46% healed and 54% failed (p?=?0.0064). No treatment-related adverse events nor relapses were documented, and technical success was achieved in all cases. The skin tropism was improved in the treatment group, and the pain scale did not differ between the two groups. CONCLUSION:The results of this randomized controlled trial suggest that the local injection of autologous micro-fragmented adipose tissue is a safe and valid therapeutic option able to improve healing rate following minor amputations of irreversible DFU. The technique overcomes several stem cell therapy-related criticisms and its potential in wound care should be better evaluated and the therapeutic indications could be expanded. TRIAL REGISTRATION:ClinicalTrials.gov number: NCT03276312. Date of registration: September 8, 2017 (retrospectively registered).

Dataset Information

Tissue Augmentation with Allograft Adipose Matrix For the Diabetic Foot in Remission.

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Tissue Augmentation with Allograft Adipose Matrix For the Diabetic Foot in Remission.

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