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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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fourweeks revision group | Experimental | Patients will be clinically revised in a 4-weeks basis |
|
| Eightweeks revision group | Active Comparator | Patients will be clinically revised in a 8-weeks basis |
|
| Twelveweeks revision group | Experimental | Patients will be clinically revised in a 12-weeks basis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 weeks revision | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate | Defined as as break in the foot skin at the epidermis and part of the dermis level. | From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks. |
| Minor amputation rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClÃnica Universitaria de PodologÃa de la Universidad Complutense de Madrid | Madrid | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41139025 | Derived | 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. |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| ID | Term |
|---|---|
| D024162 | Second-Look Surgery |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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Three arms parallel randomized clinical trial
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No masking is possible to be performed in the planned RCT due to the nature of the intervention (time dependent).
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Need for minor amputation secondary to ulcer recurrence |
| From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks. |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |