NCT07368816

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

January 8, 2026

Last Update Submit

January 23, 2026

Conditions

Diabetic FootPostoperative Wound Healing

Keywords

diabetic footwound healingpostoperative woundpilot studyoxygen-enriched oil-based dressing

Outcome Measures

Primary Outcomes (1)

  • Complete ulcer healing

    number of ulcers completely healed at 16 weeks

    16 weeks

Secondary Outcomes (4)

  • new infections

    16 weeks

  • Additional surgical debridement

    16 weeks

  • re-hospitalization

    16 weeks

  • time to healing

    16 weeks

Study Arms (2)

OEOd-Based Wound Dressing

EXPERIMENTAL

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

standard wound care

ACTIVE COMPARATOR

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)

Interventions

OEOd-based wound dressingDEVICE

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.

OEOd-Based Wound Dressing
Standard of Care (Investigator Choice)OTHER

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

standard wound care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Arezzo, AR, 52100, Italy

Location

Related Publications (1)

  • Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. No abstract available.

    PMID: 28614678RESULT

Related Links

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Alessia Scatena, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in parallel to one of two study groups: an intervention group receiving an OEOd-based wound dressing and a control group receiving standard wound care. Each participant was allocated to a single treatment group for the duration of the study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Diabetologist

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 27, 2026

Study Start

March 1, 2024

Primary Completion

December 1, 2024

Study Completion

April 30, 2025

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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

Locations

IT(1)