Diabetic FootOEOd-DFU-pilotNCT07368816
OEOd-Based Wound Dressing in Post-Surgical Diabetic Foot Ulcers
A study testing OEOd-based wound dressing in people with Diabetic Foot and Postoperative Wound Healing, run by Ospedale San Donato at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot, Postoperative Wound Healing
- What is being tested?
- OEOd-based wound dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Diabetology and Metabolism Unit, San Donato Hospital Arezzo, Local Health Authority South-East Tuscany, iTaly
Arezzo, AR, 52100
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Foot, Postoperative Wound Healing
- Being tested
- OEOd-based wound dressing, Standard of Care (Investigator Choice)
- Keywords
- diabetic foot, wound healing, postoperative wound, pilot study, oxygen-enriched oil-based dressing
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard of Care (Investigator Choice)Other
Conventional wound management for post-surgical diabetic foot ulcers according to institutional standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of Care (Investigator Choice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete ulcer healing
number of ulcers completely healed at 16 weeks
Measured: 16 weeks
Secondary outcomes (4)
new infections
number of patients with new clinically diagnosed wound infections during follow-up.
Measured: 16 weeks
Additional surgical debridement
number of patients needing additional surgical debridement of the target ulcer during follow-up.
Measured: 16 weeks
re-hospitalization
number of Hospital admission related to the target ulcer during the follow-up period.
Measured: 16 weeks
time to healing
Time from enrollment to complete ulcer healing, evaluated as an exploratory outcome.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Mar 2024
- Primary completion1 Dec 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale San Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessia Scatena, Ospedale San Donato
- Investigators
- Alessia Scatena, MD, Principal investigator, Diabetology and Metabolism Unit, San Donato Hospital Arezzo, Local Health Authority South-East Tuscany, iTaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368816
- Sponsor's protocol ID
- OEOd-AR-38235
- Other IDs
- OEOd-AR-38235
- Acronym
- OEOd-DFU-pilot
- Status last verified
- Jan 2026
- First submitted
- 8 Jan 2026
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the pilot nature of the study and to protect patient confidentiality.
Publications
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.
PubMed 28614678
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen-enriched Oil-based Dressing: a New Option for Tunneling Post-surgical Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT07368816
- Acronym / sponsor ID
- OEOd-DFU-pilot / OEOd-AR-38235
- Conditions
- Diabetic Foot, Postoperative Wound Healing
- Keywords
- diabetic foot, wound healing, postoperative wound, pilot study, oxygen-enriched oil-based dressing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ospedale San DonatoUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| OEOd-Based Wound Dressing | Experimental | Device: OEOd-based wound dressingParticipants 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. |
| standard wound care | Active comparator | Other: Standard of Care (Investigator Choice)Participants assigned to this arm received standard wound care for post-surgical diabetic foot ulcers according to institutional clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OEOd-based wound dressingTopical 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. | Device | OEOd-Based Wound Dressing |
| Standard of Care (Investigator Choice)Conventional wound management for post-surgical diabetic foot ulcers according to institutional standard clinical practice. | Other | standard wound care |
Primary outcome
Complete ulcer healing
Time frame: 16 weeks
number of ulcers completely healed at 16 weeks
4 secondary outcomes
new infections
Time frame: 16 weeks
Additional surgical debridement
Time frame: 16 weeks
re-hospitalization
Time frame: 16 weeks
time to healing
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Results publication: PubMed 28614678Armstrong 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.
- key reference on the clinical management of diabetic foot ulcersLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the pilot nature of the study and to protect patient confidentiality.
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
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Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alessia Scatena, MD principal investigator
Diabetology and Metabolism Unit, San Donato Hospital Arezzo, Local Health Authority South-East Tuscany, iTaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OEOd-based wound dressing in people with Diabetic Foot and Postoperative Wound Healing, run by Ospedale San Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete ulcer healing (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07368816, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.