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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University Hospital, Akershus Academic / other |
| Locations | 2 sites (Oslo, Nordbyhagen and 1 other locations) |
| Status | Recruiting |
| Started | January 2, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT06721754 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
- Study coordinator: Monica A Sailer, MD
- Email: monica_sailer@yahoo.no
- Phone: +47 45614728
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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BIOxHEAL plus standard care for nonhealing diabetic foot ulcers
A multicenter study tests whether applying BIOxHEAL, a placental-derived biologic, to stubborn diabetic foot ulcers helps more people heal when added to standard wound care.
-
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This observational study tests whether routine preoperative blood tests relate to the quality and behavior of mesenchymal stem cells from calcaneal bone marrow in adults undergoing foot or ankle surgery.
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L-Carnitine as an add-on for healing diabetic foot ulcers
This study tests whether taking L-Carnitine helps wound healing in adults with diabetic foot ulcers, alongside standard diabetes and wound care.
-
THERAVEX Tissue Care Spray Plus for Healing of Skin Wounds and Ulcers
This observational review tests whether THERAVEX Tissue Care Spray Plus, used with standard wound care, helps heal various skin wounds and chronic ulcers in adults.
-
Pulsating electromagnetic field therapy for diabetic foot ulcers
This trial tests whether a PEMF device called CRAD ULCER X-01 helps heal chronic diabetic foot ulcers when added to standard wound care.
-
Transverse tibial bone transport to help heal chronic diabetic foot ulcers
This study tests a surgical approach called transverse tibial bone transport to see if it can help heal long‑lasting diabetic foot ulcers and prevent limb loss in adults with limited treatment options.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.