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Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy

NCT06721754 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-04

No results posted yet for this study

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

Conditions

  • Diabetic Foot Ulcer

Interventions

PROCEDURE

Negative Pressure Wound Treatment

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

Sponsors & Collaborators

  • South-Eastern Norway Regional Health Authority

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • Ostfold Hospital Trust

    collaborator OTHER

  • University Hospital, Akershus

    lead OTHER

Principal Investigators

  • Per-Henrik Randsborg, Professor; MD · University Hospital, Akershus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06721754 on ClinicalTrials.gov