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

NCT07368816 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-27

No results posted yet for this study

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.

Conditions

  • Diabetic Foot
  • Postoperative Wound Healing

Interventions

DEVICE

OEOd-based wound dressing

Topical application of an OEOd-based wound dressing to post-surgical diabetic foot ulcers according to routine clinical practice, in addition to standard multidisciplinary diabetic foot care.

OTHER

Standard of Care (Investigator Choice)

Conventional wound management for post-surgical diabetic foot ulcers according to institutional standard clinical practice.

Sponsors & Collaborators

  • Ospedale San Donato

    lead OTHER

Principal Investigators

  • Alessia Scatena, MD · Diabetology and Metabolism Unit, San Donato Hospital Arezzo, Local Health Authority South-East Tuscany, iTaly

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-12-01
Completion
2025-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07368816 on ClinicalTrials.gov