Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06721754

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy | DecenTrialz