CompletedNot Applicable

OEOd-Based Wound Dressing in Post-Surgical Diabetic Foot Ulcers

Italy40 participantsStarted 2024-03-01

Plain-language summary

This study is a prospective randomized controlled pilot study evaluating the efficacy and safety of an OEOd-based wound dressing compared with standard wound care in patients with post-surgical diabetic foot ulcers. Participants were randomly assigned at enrollment to receive either the OEOd-based dressing or standard therapy. The primary outcome was complete ulcer healing at 16 weeks. Secondary outcomes included new infections, need for additional surgical debridement, re-hospitalization, and time to healing. The study was designed to provide preliminary estimates of treatment effect and feasibility to inform future larger randomized trials.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults (≥18 years) with diabetes mellitus * Presence of a post-surgical diabetic foot ulcer * Eligibility for topical wound treatment * Ability to provide written informed consent Exclusion Criteria: * Active malignancy * Severe systemic infection or sepsis * Known hypersensitivity to components of the wound dressing * Inability to comply with study procedures or follow-up * Participation in another interventional clinical study during the same period

What they're measuring

Complete ulcer healing

Timeframe: 16 weeks

Trial details

NCT IDNCT07368816

SponsorOspedale San Donato

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-01

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