A Wound Environment Control System to Avoid Major Amputation in Diabetic Foot Ulcers

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TL;DR

A 58-year-old woman with a severe diabetic foot ulcer at high risk of transtibial amputation was successfully treated using Vistacare®, a novel wound environment control system that modulates moisture, temperature, and oxygen levels. After two weeks of treatment, the wound developed healthy granulation tissue, and complete epithelialization was achieved by June 2021, allowing the patient to walk normally with therapeutic shoes. This case suggests that controlled wound environment therapy may serve as a complementary treatment to avoid major amputation when standard care is insufficient or negative pressure wound therapy is painful or ineffective.

Full summary

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**Background:** Diabetic foot syndrome remains a major cause of non-traumatic amputation worldwide. Wound environment factors such as moisture, temperature, and oxygen are critical for wound closure. The Vistacare® device (DTAMedical SAS, Loulle, France) is a novel system that controls these parameters within a closed chamber where the affected leg is placed. It offers three predetermined settings: Set A (debridement: average moisture 80±10%, average oxygen 40±10%), Set B (granulation: average moisture 60±20%, oxygen varying between 20% and 50% with cyclic variations), and Set C (epithelialization: average moisture 50±10%, average oxygen 30±10%). Temperature is maintained between 32 and 34 °C across all sets. No dressing is required during treatment, and the device is typically used for 10–14 days of hospitalization with at least 16 hours of daily application.

**Methods:** This is a single case report of a 58-year-old woman admitted to a diabetic foot unit in January 2021. She was diagnosed with diabetes in 2014; type 2 diabetes was ruled out due to absence of family history, overweight, or metabolic syndrome (BMI at diagnosis 22 kg·m⁻²). Type 1 diabetes antibodies were absent, and CT showed an atrophic pancreas without history of pancreatitis, alcohol abuse, or lithiasis. Diabetes complications included distal polyneuropathy, lower limb arteriopathy, and coronary artery disease. The patient never smoked. In July 2020, she developed a wound on her right first toe due to shoe rubbing, complicated by infection, osteomyelitis, and necrosis. Despite first ray amputation with endoluminal revascularization in August 2020, progression led to transmetatarsal amputation on 14 January 2021 and Lisfranc amputation on 19 January 2021, with prolonged angioplasty of each leg artery. Bone samples grew Staphylococcus meti-S, Enterococcus faecalis, and Corynebacterium striatum; histology confirmed acute osteomyelitis. Antibiotic therapy with cefoxitin and vancomycin was later adapted to rifampicin and vancomycin for 6 weeks. Upon admission to the diabetic foot unit on 26 January 2021, the wound measured 63×42×36 mm (length×width×depth), was covered in fibrin, painful during debridement, and classified as SINBAD 4 and IDSA 3o. Renal function was normal, HbA1c was 5.9%, C-LDL 1.1 nmol/L under statin, blood pressure controlled, PCR 21 mg/L with normal neutrophil count.

**Key Results:** Vistacare® treatment was initiated with Set A (high moisture for debridement) predominantly during the first week. By Day 3, slough was removed after light mechanical debridement without pain. During the second week, Sets A and B were applied equally to promote debridement and granulation. Offloading was maintained throughout. After 2 weeks, the wound exhibited healthy granulation tissue. A wound dressing was applied until a skin graft was performed on 10 March. Complete epithelialization was achieved by 15 June. By August, the patient could walk normally using therapeutic shoes. Major amputation (transtibial) was avoided.

**Clinical Implications:** This first report of Vistacare® use in a severe diabetic foot ulcer demonstrates potential for avoiding major amputation in high-risk patients. The device should be considered complementary to standard care, particularly for ischemic wounds when standard treatments fail or negative pressure wound therapy is painful or ineffective. The device is currently being evaluated in an open-label, prospective, multi-center study (NCT03790202). Additional reports are needed to better define its role in diabetic foot ulcer management.