Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy

Sponsor
University Hospital, Akershus
Study ID
NCT06721754
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Dec 6, 2024
Start date
Jan 2, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Standard Wound Treatment
  • Active Comparator: Negative Pressure Wound Treatment

Primary Outcome Measure

Number of lower extremity amputations [ Time Frame: One year from inclusion ]

Central Contacts

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