RecruitingNot ApplicableNCT06721754

Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy

Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy: A Randomized Controlled Trial


Sponsor

University Hospital, Akershus

Enrollment

50 participants

Start Date

Jan 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Male and non-pregnant female above 18 years with a diabetic foot ulcer in need of surgical debridement or forefoot amputation

Exclusion Criteria6

  • 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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Interventions

PROCEDURENegative Pressure Wound Treatment

Negative Pressure Wound Treatment promotes healing by applying subatmospheric pressure to reduce inflammatory exudate and stimulate granulation tissue.


Locations(2)

Department of Orthopedic Surgery, Akershus University Hospital

Oslo, Nordbyhagen, Norway

Ostfold Hospital

Grålum, Norway

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NCT06721754


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