Actively Recruiting
Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy
Led by University Hospital, Akershus · Updated on 2026-05-04
50
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Akershus
Lead Sponsor
S
South-Eastern Norway Regional Health Authority
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and non-pregnant female above 18 years with a diabetic foot ulcer in need of surgical debridement or forefoot amputation
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Department of Orthopedic Surgery, Akershus University Hospital
Oslo, Nordbyhagen, Norway, 1478
Actively Recruiting
2
Ostfold Hospital
Grålum, Norway, 1714
Not Yet Recruiting
Research Team
M
Monica A Sailer, MD
CONTACT
P
Per-Henrik Randsborg Randsborg, Professor, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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