Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Comparing Negative Pressure Wound Therapy to Standard Care for Diabetic Foot Ulcers

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

Run by University Hospital, Akershus · NCT06721754 · Data updated 2026-11-12

This study is testing if a special wound treatment called Negative Pressure Wound Therapy works better than standard care for healing diabetic foot ulcers.

More Diabetic Foot Ulcer trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment50 (estimated)
SponsorUniversity Hospital, Akershus
Academic / other
Locations2 sites (Oslo, Nordbyhagen and 1 other locations)
StatusRecruiting
StartedJanuary 2, 2025
Main results expectedDecember 31, 2027
Study endsDecember 31, 2028
Registry record updatedMay 4, 2026
Trial IDNCT06721754 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adult males and non-pregnant females over 18 years old with diabetic foot ulcers requiring surgical intervention.

Probably not a fit

Patients who have previously undergone leg amputation due to diabetes or those unable to ambulate may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of Negative Pressure Wound Therapy (NPWT) compared to standard wound care in treating diabetic foot ulcers (DFUs). Participants will receive either NPWT or standard care after surgical debridement and will be monitored for one year to assess outcomes such as the rate of major amputations and the need for additional surgeries. The study addresses a significant health issue, as DFUs can lead to severe complications, including amputations and high healthcare costs. By closely following patients, the study seeks to provide insights into the best treatment options for this challenging condition.

Why it matters

Potential benefit: If successful, this study could lead to improved healing rates and reduced amputation rates for patients with diabetic foot ulcers.

How similar studies have gone: While there have been studies on wound care for diabetic foot ulcers, the specific comparison of NPWT to standard care in this context is less common, making this approach somewhat novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

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

Exclusion Criteria:

* 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

Where it's running

  • Department of Orthopedic Surgery, Akershus University Hospital
    Oslo, Nordbyhagen, Norway
    Recruiting
  • Ostfold Hospital
    Grålum, Norway
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.