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Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Akershus
NCT06721754 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this study is to learn if the clinical effects of Negative Pressure Wound Therapy (NPWT) is better, worse or the same as standard wound care for patients with diabetic foot ulcers (DFUs). The main questions it aims to answer are: * Will there be a difference in the number of major amputations between the groups during the first year? * Will one of the treatments require more surgeries and longer hospital stays? All participants will: * be treated with NPWT or standard wound care for their diabetic foot ulcer after surgery * be followed closely at the out-patient clinic for one year after treatment

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📋 Eligibility rules (as published)
Inclusion Criteria: * Male and non-pregnant female above 18 years with a diabetic foot ulcer in need of surgical debridement or forefoot amputation Exclusion Criteria: * Previous leg amputation due to diabetes * Unable to ambulate on feet * Unlikely to adhere to treatment and/or follow-up * Unable to complete questionnaire * Active or ongoing cancer treatment * In need of amputation at a higher level than metatarsal or more than two metatarsals
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What it tests

  • Negative Pressure Wound Treatment
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Where

2 sites
Department of Orthopedic Surgery, Akershus University Hospital
Oslo, Norway
Ostfold Hospital
Grålum, Norway
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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