Diabetic Foot UlcerDIFUNCT04939038
Timing of Revascularization in Patients With Diabetic Foot Ulcer and Non-critical Peripheral Artery Disease
A study testing Revascularization and Standard wound care in people with Diabetic Foot Ulcer, run by Insel Gruppe AG, University Hospital Bern at 4 sites in Switzerland.
Trial summary
This study investigates whether, compared to standard treatment, immediate restoration of blood flow (revascularization) can reduce complications and improve diabetic foot ulcer healing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Revascularization and Standard wound care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 25 Jan 2022to 18 Sep 2024
- 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
- Informed consent as documented by signature
- Patients that are at least 18 years old
- Patients that have at least one DFU(s) of ≥ 0.2 cm2 and ≤ 10 cm2 as assessed by the ruler method multiplying the greatest length and width of the ulcer after debridement to determine the surface area. The largest eligible ulcer (≤ 10 cm2) will be defined as index ulcer and the corresponding extremity as index limb (in case of multiple equally sized ulcers the following rules will apply: If on different feet, the dominant side and if on the same foot, the more peripheral one will be the index ulcer)
- Patients that have non-critical LEAD of the index leg, defined by a single non-invasive examination at screening:
- Ankle brachial index (ABI) ≥ 0.5 and ≤ 0.9 AND absolute ankle pressure ≥ 50 mmHg OR
- ABI > 0.9 OR incompressible ankle pressures AND toe brachial index (TBI) ≤ 0.7 AND absolute toe pressure ≥ 30 mmHg
- Patients on medical treatment for glycemic control with diagnosis of diabetes mellitus that was assessed by criteria as recommended by the guideline 2019 "ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD". Or patient without medical treatment but diagnosed with diabetes mellitus via HbA1c.
- Patients with life expectancy > 12 months and without any disabilities due to end-stage cancer, heart failure, severe chronic obstructive pulmonary disease (COPD), or dementia
Who cannot join
- Critical limb ischemia of the index leg defined as ABI ≤ 0.4 (or absolute ankle pressure < 50 mmHg)
- No option to assess for toe pressure due to any reason at baseline if ABI > 0.9 or incompressible ankle pressures and patient inclusion is based on the toe pressure criteria.
- Need for major amputation
- Severe infection at the index foot according to IDSA classification
- Patient refuses minor amputation despite strong recommendation due to severe infection, necrosis or osteomyelitis at screening assessment
- Any revascularization procedure at the index leg within 3 months before randomization
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- Positive urine or blood pregnancy test result, breast feeding or intention to become pregnant
- Non-compliance for any reason to procedures or study assessments (e.g. due to cognitive impairment or geographic distance)
- Participation in another drug study within the 30 days preceding or during the present study
- Untreated known antiphospholipid antibody syndrome and polycythaemia vera
- Known significant bleeding risk, or known coagulation disorder (INR > 3.0 and platelet count < 30,000/mm3) without any option to correct within 7 calendar days after initial wound assessment
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
Clinic for Angiology, University of Basel
Basel
University Clinic for Angiology, University Hospital Inselspital, Berne
Bern, 3010
Angiologie, Luzerner Kantonsspital
Lucerne
Clinic for Vascular Surgery, Kantonsspital St. Gallen
Sankt Gallen
About this study
Official title: Timing of Revascularization in Patients With Diabetic Foot Ulcer and Non-critical Peripheral Artery Disease: a Randomized, Controlled Trial
This study investigates whether, compared to standard treatment, immediate restoration of blood flow (revascularization) can reduce complications and improve diabetic foot ulcer healing.
Read the detailed description
Background: In approximately 80% of diabetes-related lower extremity amputations, patients suffer from a foot ulcer, often caused by lower extremity arterial disease. Due to lower extremity arterial disease (LEAD), diabetic patients with foot ulcers often require lower limb amputation. Achieving arterial supply (revascularization) to the ulcer is the most important factor in healing the diabetic foot ulcer and reduces the risk of amputation. The current standard of care recommends revascularization after six weeks in patients with low-grade arterial disease of the lower extremities and nonhealing foot ulcer. The aim of this study is to demonstrate that in patients with low grade arterial disease of the lower extremities and diabetic foot ulcers, immediate revascularization results in fewer cardiovascular problems and amputations, as well as improved ulcer healing, compared to the current standard of care.
Study procedure: After inclusion in the study, participants will be randomized into the control arm or the active arm. In the control arm standard wound care will be performed. In the active arm, revascularization will be performed on top of standard wound care within 7 days after randomization. Post-revascularization analysis on ankle- and toe pressure, laboratory analysis, and wound care team assessment and therapy will be performed 24 h post operation.
Follow up will be on 45, 90, 180 and 365 day for patients of both arms, where ankle- and toe pressure, laboratory analysis, and wound care team assessment and therapy will be performed.
Number of Participants: 240 participants in total, 120 per treatment arm
Study duration: 4 years
Study Centre(s): International multi-centre study with approximately 8-12 centres
Participating countries: Switzerland, Germany
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Revascularization, Standard wound care
- Keywords
- Revascularization, Lower extremity arterial disease, Non-critical peripheral artery disease
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RevascularizationProcedure or surgery
Depending on the condition of the patients, patients will have either endovascular or surgical revascularization
Standard wound careProcedure or surgery
Standard wound care according to guidelines
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Standard wound care for diabetic wound ulcer Receives: Procedure: Standard wound care |
| Immediate revascularization | Experimental | Patient will have revascularization 0 - 7 days after initial wound assessment and then receive standard wound care for diabetic wound ulcer Receives: Procedure: Revascularization; Procedure: Standard wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with cardiovascular death
Measured: up to 12 months
Number of patients with non-fatal myocardial infarction or all-cause stroke
Measured: up to 12 months after randomization
Number of patients with major amputation
Measured: up to 12 months after randomization
Number of patients with Minor amputation
Measured: up to 12 months after randomization
Number of patients with missed diabetic foot ulcer healing
i.e. Incomplete epithelization of the index ulcer at 90 days
Measured: 90 days after randomization
Number of patients with delayed diabetic foot ulcer healing
Reduction of wound size of less than 50% at 45 days
Measured: 45 days after randomization
Secondary outcomes (7)
Number of patients with new ulcer of the index foot
Measured: up to 12 months after randomization
Number of patients with all clinically-driven revascularizations at the index limb
excluding primary revascularization in the immediate re-vascularization group
Measured: up to 12 months after randomization
Each component of the primary outcome individually
Primary outcome 1 to 6
Measured: up to 12 months after randomization
Number of in-hospital days and costs
(based on Disease-Related Group codes) as a measure of health service utilization
Measured: up to 12 months after randomization
Change in quality of life (QoL) assessed by the Cardiff Wound Impact Schedule questionnaire
Scores are transformed onto a scale of 0 - 100, a high score represents a 'good' QoL and a low score represent a 'poor' QoL
Measured: from baseline to 90 days and 12 months after randomization
Number of patients with major amputation-free survival
death of any cause or major amputation
Measured: up to 12 months after randomization
Number of patients with all-cause death
Measured: up to 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start25 Jan 2022
- Primary completion18 Sep 2024
- Study completion18 Sep 2024
Why it stopped: High pre-screening failure and insufficient recruited patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. med. Iris Baumgartner, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939038
- Sponsor's protocol ID
- 1495 DIFU
- Acronym
- DIFU
- Status last verified
- Dec 2024
- First submitted
- 23 Jun 2021
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Revascularization in Patients With Diabetic Foot Ulcer and Non-critical Peripheral Artery Disease: a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04939038
- Acronym / sponsor ID
- DIFU / 1495 DIFU
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Revascularization, Lower extremity arterial disease, Non-critical peripheral artery disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High pre-screening failure and insufficient recruited patients
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- University of Bern, Swiss National Science Foundation
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 25 Jun 2021 (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 investigates whether, compared to standard treatment, immediate restoration of blood flow (revascularization) can reduce complications and improve diabetic foot ulcer healing.
Detailed description
Background: In approximately 80% of diabetes-related lower extremity amputations, patients suffer from a foot ulcer, often caused by lower extremity arterial disease. Due to lower extremity arterial disease (LEAD), diabetic patients with foot ulcers often require lower limb amputation. Achieving arterial supply (revascularization) to the ulcer is the most important factor in healing the diabetic foot ulcer and reduces the risk of amputation. The current standard of care recommends revascularization after six weeks in patients with low-grade arterial disease of the lower extremities and nonhealing foot ulcer. The aim of this study is to demonstrate that in patients with low grade arterial disease of the lower extremities and diabetic foot ulcers, immediate revascularization results in fewer cardiovascular problems and amputations, as well as improved ulcer healing, compared to the current standard of care.
Study procedure: After inclusion in the study, participants will be randomized into the control arm or the active arm. In the control arm standard wound care will be performed. In the active arm, revascularization will be performed on top of standard wound care within 7 days after randomization. Post-revascularization analysis on ankle- and toe pressure, laboratory analysis, and wound care team assessment and therapy will be performed 24 h post operation.
Follow up will be on 45, 90, 180 and 365 day for patients of both arms, where ankle- and toe pressure, laboratory analysis, and wound care team assessment and therapy will be performed.
Number of Participants: 240 participants in total, 120 per treatment arm
Study duration: 4 years
Study Centre(s): International multi-centre study with approximately 8-12 centres
Participating countries: Switzerland, Germany
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Procedure: Standard wound careStandard wound care for diabetic wound ulcer |
| Immediate revascularization | Experimental | Procedure: Revascularization, Procedure: Standard wound carePatient will have revascularization 0 - 7 days after initial wound assessment and then receive standard wound care for diabetic wound ulcer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed consent as documented by signature
- Patients that are at least 18 years old
- Patients that have at least one DFU(s) of ≥ 0.2 cm2 and ≤ 10 cm2 as assessed by the ruler method multiplying the greatest length and width of the ulcer after debridement to determine the surface area. The largest eligible ulcer (≤ 10 cm2) will be defined as index ulcer and the corresponding extremity as index limb (in case of multiple equally sized ulcers the following rules will apply: If on different feet, the dominant side and if on the same foot, the more peripheral one will be the index ulcer)
- Patients that have non-critical LEAD of the index leg, defined by a single non-invasive examination at screening:
- Patients on medical treatment for glycemic control with diagnosis of diabetes mellitus that was assessed by criteria as recommended by the guideline 2019 "ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD". Or patient without medical treatment but diagnosed with diabetes mellitus via HbA1c.
Key exclusion criteria (11 listed)
- Critical limb ischemia of the index leg defined as ABI ≤ 0.4 (or absolute ankle pressure < 50 mmHg)
- No option to assess for toe pressure due to any reason at baseline if ABI > 0.9 or incompressible ankle pressures and patient inclusion is based on the toe pressure criteria.
- Need for major amputation
- Severe infection at the index foot according to IDSA classification
- Patient refuses minor amputation despite strong recommendation due to severe infection, necrosis or osteomyelitis at screening assessment
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 |
|---|---|---|
| RevascularizationDepending on the condition of the patients, patients will have either endovascular or surgical revascularization | Procedure or surgery | Immediate revascularization |
| Standard wound careStandard wound care according to guidelines | Procedure or surgery | Control Arm, Immediate revascularization |
Primary outcome
Number of patients with cardiovascular death
Time frame: up to 12 months
Number of patients with non-fatal myocardial infarction or all-cause stroke
Time frame: up to 12 months after randomization
Number of patients with major amputation
Time frame: up to 12 months after randomization
Number of patients with Minor amputation
Time frame: up to 12 months after randomization
Number of patients with missed diabetic foot ulcer healing
Time frame: 90 days after randomization
i.e. Incomplete epithelization of the index ulcer at 90 days
Number of patients with delayed diabetic foot ulcer healing
Time frame: 45 days after randomization
Reduction of wound size of less than 50% at 45 days
7 secondary outcomes
Number of patients with new ulcer of the index foot
Time frame: up to 12 months after randomization
Number of patients with all clinically-driven revascularizations at the index limb
Time frame: up to 12 months after randomization
Each component of the primary outcome individually
Time frame: up to 12 months after randomization
Number of in-hospital days and costs
Time frame: up to 12 months after randomization
Change in quality of life (QoL) assessed by the Cardiff Wound Impact Schedule questionnaire
Time frame: from baseline to 90 days and 12 months after randomization
Number of patients with major amputation-free survival
Time frame: up to 12 months after randomization
Number of patients with all-cause death
Time frame: up to 12 months after randomization
Results and safety
The study was stopped early (reason given: High pre-screening failure and insufficient recruited patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcer
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PAW-Hydrogel for Chronic Wound Healing
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Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
Active, not recruiting
EDX110 Randomized Control Trial for Treatment of DFUs
Wound Heal, Diabetic Foot Ulcer
Recruiting
DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
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.
Prof. Dr. med. Iris Baumgartner principal investigator
Insel Gruppe AG, University Hospital Bern
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revascularization and Standard wound care in people with Diabetic Foot Ulcer, run by Insel Gruppe AG, University Hospital Bern at 4 sites in Switzerland.
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 8 inclusion and 11 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: stopped early, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. 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 was stopped early (reason given: High pre-screening failure and insufficient recruited patients). Results are not available in the source record.
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?
Number of patients with cardiovascular death (time frame: up to 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2024.