OEOd-Based Wound Dressing in Post-Surgical Diabetic Foot Ulcers (OEOd-DFU-pilot)

January 23, 2026 updated by: Alessia Scatena, Ospedale San Donato

Oxygen-enriched Oil-based Dressing: a New Option for Tunneling Post-surgical Diabetic Foot Ulcers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was designed as a prospective randomized controlled pilot study to evaluate the efficacy and safety of an OEOd-based wound dressing compared with standard wound care in patients with post-surgical diabetic foot ulcers. Adult patients with diabetes mellitus presenting with a post-surgical foot ulcer were prospectively enrolled and randomly assigned at the time of enrollment to receive either the OEOd-based wound dressing or standard therapy, according to a simple random allocation procedure.

All patients received standard multidisciplinary diabetic foot care, including surgical management when indicated, infection control, off-loading, and metabolic optimization. The investigational intervention consisted of a topical OEOd-based wound dressing applied according to routine clinical practice.

The primary endpoint of the study was complete ulcer healing at 16 weeks, defined as full epithelialization of the target lesion without drainage. Secondary endpoints included the occurrence of new infections, the need for additional surgical debridement, re-hospitalization during follow-up, and time to healing, which was evaluated as an exploratory outcome.

Given the pilot nature of the study, no formal a priori sample size calculation was performed. The trial was intended to provide preliminary estimates of treatment effect and feasibility to inform the design of future larger randomized controlled studies.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • AR
      • Arezzo, AR, Italy, 52100
        • Diabetology and Metabolism Unit, San Donato Hospital Arezzo, Local Health Authority South-East Tuscany, iTaly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OEOd-Based Wound Dressing
Participants assigned to this arm received a topical OEOd-based wound dressing applied to post-surgical diabetic foot ulcers according to routine clinical practice, in addition to standard multidisciplinary diabetic foot care.
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.
Active Comparator: standard wound care
Participants assigned to this arm received standard wound care for post-surgical diabetic foot ulcers according to institutional clinical practice.
Other: Standard of Care (Investigator Choice)
Conventional wound management for post-surgical diabetic foot ulcers according to institutional standard clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete ulcer healing
Time Frame: 16 weeks
number of ulcers completely healed at 16 weeks
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
new infections
Time Frame: 16 weeks
number of patients with new clinically diagnosed wound infections during follow-up.
16 weeks
Additional surgical debridement
Time Frame: 16 weeks
number of patients needing additional surgical debridement of the target ulcer during follow-up.
16 weeks
re-hospitalization
Time Frame: 16 weeks
number of Hospital admission related to the target ulcer during the follow-up period.
16 weeks
time to healing
Time Frame: 16 weeks
Time from enrollment to complete ulcer healing, evaluated as an exploratory outcome.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Donato

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

January 8, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OEOd-AR-38235 (Other Identifier: Ethics Committee of the Tuscany Region, South-East Area)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to the pilot nature of the study and to protect patient confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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