Diabetic FootDiatimeNCT06143215
Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons with Diabetes and Remission
A study testing 4 weeks revision in people with Diabetic Foot, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The goal of this three arms randomized clinical trial is to compare different revision times in persons with diabetes at high risk of suffering a diabetic foot reulceration (patients in remission). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- 4 weeks revision
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2024to 15 Feb 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
- Patients aged 18 years or older.
- Type 1 or type 2 diabetes.
- Presence of diabetic polyneuropathy (diagnosed as an inability to sense the pressure of a 10-g Semmes-Weinstein monofilament at three plantar foot sites and/or a vibration perception threshold >25 V, as assessed using a bio-tensiometer.
- Patients classified as high-risk patients (risk 3 patients according to the IWGDF guidance). Previous healed diabetic foot ulcer.
Who cannot join
- Active diabetic foot ulcers during inclusion.
- Active Charcot foot process.
- Conditions other than diabetes also associated with foot ulcers were excluded from the study as well.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clínica Universitaria de Podología de la Universidad Complutense de Madrid
Madrid, Madrid, 28040
About this study
Official title: Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons with Diabetes and Remission: a Three Arm Double Blind Randomized Clinical Trial
The goal of this three arms randomized clinical trial is to compare different revision times in persons with diabetes at high risk of suffering a diabetic foot reulceration (patients in remission). The literature suggests to clinically check the patients in a 4-12 weeks basis, despite this, this recommendation is based in expert opinions.
The main question it aims to answer is:
- Does different revision times could affect the reulceration rate in persons with diabetes in remission. Different revision time will be 2 weeks, 4 weeks and 6 weeks.
Read the detailed description
The planned RCT try to elucidate if there exist any difference in ulcer recurrence between different revisions times in persons with a previous healed diabetic foot ulcer and currently under remission.
There will exist three different groups for analyses after randomization:
- Group 1: patients revised every fourweeks.
- Group 2: patients revised every eightweeks.
- Group 3: patients revised every twelveweeks.
Main outcome measure will include:
- Recurrence: the outcome measure was based on recurrent events in the foot in a binary basis (patient with a recurrent event or patient without a recurrent event), as defined according to the IWGDF guidelines. Recurrent events were considered as breaks in the foot skin at the epidermis and part of the dermis level.
Secondary outcome measure will include:
- Minor lesions: defined as non ulcerative lesions of the skin on the plantar aspect of the foot and included abundant callus, hemorrhage, or a blister.
- Minor amputations: evaluated in a monthly basis during the 1-year prospective period
Follow-up period: all the sample will be followed-up depending on the randomization group up to a 1-year prospective period. In every visit de principal investigator will perform debridement of high-risk points, such as minor lesions or calluses.
- Conditions
- Diabetic Foot
- Being tested
- 4 weeks revision
- Keywords
- Diabetic foot, Reulceration, Prevention
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 weeks revisionBehavioural
In the literature is described to clinically revise patients in a 4-6 weeks basis, despite this expert recommendation, no previous research has clinically evaluated if 4-8-12 weeks revision times could change diabetic foot reulceration rate.
| Study group | Role | What they receive |
|---|---|---|
| Fourweeks revision group | Experimental | Patients will be clinically revised in a 4-weeks basis Receives: Behavioral: 4 weeks revision |
| Eightweeks revision group | Active comparator | Patients will be clinically revised in a 8-weeks basis Receives: Behavioral: 4 weeks revision |
| Twelveweeks revision group | Experimental | Patients will be clinically revised in a 12-weeks basis Receives: Behavioral: 4 weeks revision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Defined as as break in the foot skin at the epidermis and part of the dermis level.
Measured: From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.
Secondary outcomes (2)
Minor lesion rate
Defined as non ulcerative lesions of the skin on the plantar aspect of the foot and included abundant callus, hemorrhage, or a blister.
Measured: From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.
Minor amputation rate
Need for minor amputation secondary to ulcer recurrence
Measured: From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start10 Jan 2024
- Primary completion9 Dec 2024
- Study completion15 Feb 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.
- More trials run by Universidad Complutense de MadridThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three arms parallel randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mateo López-Moral, DPM, PhD, Universidad Complutense de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143215
- Sponsor's protocol ID
- Diatime_061123
- Acronym
- Diatime
- Status last verified
- May 2024
- First submitted
- 10 Nov 2023
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lopez-Moral M, Garcia-Madrid M, Garcia-Morales E, Garcia-Alvarez Y, Alvaro-Afonso FJ, Lazaro-Martinez JL. Comparison of 4, 8, and 12 week screening and foot care frequencies in persons in remission: The DIATIME comparative efficacy study - A randomized clinical trial. Diabetes Res Clin Pract. 2025 Dec;230:112962. doi: 10.1016/j.diabres.2025.112962. Epub 2025 Oct 24.
PubMed 41139025
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons with Diabetes and Remission: a Three Arm Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06143215
- Acronym / sponsor ID
- Diatime / Diatime_061123
- Conditions
- Diabetic Foot
- Keywords
- Diabetic foot, Reulceration, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 9 Dec 2024 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 22 Nov 2023 (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.
The goal of this three arms randomized clinical trial is to compare different revision times in persons with diabetes at high risk of suffering a diabetic foot reulceration (patients in remission). The literature suggests to clinically check the patients in a 4-12 weeks basis, despite this, this recommendation is based in expert opinions.
The main question it aims to answer is:
- Does different revision times could affect the reulceration rate in persons with diabetes in remission. Different revision time will be 2 weeks, 4 weeks and 6 weeks.
Detailed description
The planned RCT try to elucidate if there exist any difference in ulcer recurrence between different revisions times in persons with a previous healed diabetic foot ulcer and currently under remission.
There will exist three different groups for analyses after randomization:
- Group 1: patients revised every fourweeks.
- Group 2: patients revised every eightweeks.
- Group 3: patients revised every twelveweeks.
Main outcome measure will include:
- Recurrence: the outcome measure was based on recurrent events in the foot in a binary basis (patient with a recurrent event or patient without a recurrent event), as defined according to the IWGDF guidelines. Recurrent events were considered as breaks in the foot skin at the epidermis and part of the dermis level.
Secondary outcome measure will include:
- Minor lesions: defined as non ulcerative lesions of the skin on the plantar aspect of the foot and included abundant callus, hemorrhage, or a blister.
- Minor amputations: evaluated in a monthly basis during the 1-year prospective period
Follow-up period: all the sample will be followed-up depending on the randomization group up to a 1-year prospective period. In every visit de principal investigator will perform debridement of high-risk points, such as minor lesions or calluses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three arms parallel randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Fourweeks revision group | Experimental | Behavioral: 4 weeks revisionPatients will be clinically revised in a 4-weeks basis |
| Eightweeks revision group | Active comparator | Behavioral: 4 weeks revisionPatients will be clinically revised in a 8-weeks basis |
| Twelveweeks revision group | Experimental | Behavioral: 4 weeks revisionPatients will be clinically revised in a 12-weeks basis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years or older.
- Type 1 or type 2 diabetes.
- Presence of diabetic polyneuropathy (diagnosed as an inability to sense the pressure of a 10-g Semmes-Weinstein monofilament at three plantar foot sites and/or a vibration perception threshold >25 V, as assessed using a bio-tensiometer.
- Patients classified as high-risk patients (risk 3 patients according to the IWGDF guidance). Previous healed diabetic foot ulcer.
Key exclusion criteria (3 listed)
- Active diabetic foot ulcers during inclusion.
- Active Charcot foot process.
- Conditions other than diabetes also associated with foot ulcers were excluded from the study as well.
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 |
|---|---|---|
| 4 weeks revisionIn the literature is described to clinically revise patients in a 4-6 weeks basis, despite this expert recommendation, no previous research has clinically evaluated if 4-8-12 weeks revision times could change diabetic foot reulceration rate. | Behavioural | Eightweeks revision group, Fourweeks revision group, Twelveweeks revision group |
Primary outcome
Recurrence rate
Time frame: From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.
Defined as as break in the foot skin at the epidermis and part of the dermis level.
2 secondary outcomes
Minor lesion rate
Time frame: From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.
Minor amputation rate
Time frame: From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 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 19 Mar 2025.
- Derived from this study: PubMed 41139025Lopez-Moral M, Garcia-Madrid M, Garcia-Morales E, Garcia-Alvarez Y, Alvaro-Afonso FJ, Lazaro-Martinez JL. Comparison of 4, 8, and 12 week screening and foot care frequencies in persons in remission: The DIATIME comparative efficacy study - A randomized clinical trial. Diabetes Res Clin Pract. 2025 Dec;230:112962. doi: 10.1016/j.diabres.2025.112962. Epub 2025 Oct 24.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4 weeks revision in people with Diabetic Foot, run by Universidad Complutense de Madrid at 1 site in Spain.
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 3 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 19 Mar 2025. 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 Spain. 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?
Recurrence rate (time frame: From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 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 NCT06143215, 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 19 Mar 2025.