Comparing Negative Pressure Wound Therapy to Standard Care for Diabetic Foot Ulcers
Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy: A Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Akershus Academic / other |
| Locations | 2 sites (Oslo, Nordbyhagen and 1 other locations) |
| Trial ID | NCT06721754 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adult males and non-pregnant females over 18 years old with diabetic foot ulcers requiring surgical intervention.
Not a fit: Patients who have previously undergone leg amputation due to diabetes or those unable to ambulate may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Oslo, Nordbyhagen and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.