NCT06721754 Diabetes Related Foot Ulcers With Negative Pressure Wound Therapy
| NCT ID | NCT06721754 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Akershus |
| Condition | Diabetic Foot Ulcer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-01-02 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-01-02 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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
Contact & Investigator
Per-Henrik Randsborg, Professor; MD
STUDY DIRECTOR
University Hospital, Akershus
Frequently Asked Questions
Who can join the NCT06721754 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diabetic Foot Ulcer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06721754 currently recruiting?
Yes, NCT06721754 is actively recruiting participants. Contact the research team at monica_sailer@yahoo.no for enrollment information.
Where is the NCT06721754 trial being conducted?
This trial is being conducted at Oslo, Norway, Grålum, Norway.
Who is sponsoring the NCT06721754 clinical trial?
NCT06721754 is sponsored by University Hospital, Akershus. The principal investigator is Per-Henrik Randsborg, Professor; MD at University Hospital, Akershus. The trial plans to enroll 50 participants.