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

San Donato Group (GSD)

Status: Completed

Conditions: Diabetic Foot; Postoperative Wound Healing

Treatments: Other: Standard of Care (Investigator Choice); Device: OEOd-based wound dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT07368816

OEOd-AR-38235 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

OEOd-Based Wound Dressing

Experimental group

Description:

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.

Treatment:

Device: OEOd-based wound dressing

standard wound care

Active Comparator group

Description:

Participants assigned to this arm received standard wound care for post-surgical diabetic foot ulcers according to institutional clinical practice.

Treatment:

Other: Standard of Care (Investigator Choice)