Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons with Diabetes and Remission

NCT ID: NCT06143215

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-10
• Study Completion Date: 2025-02-15

Brief 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). 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.

Conditions

Diabetic Foot

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Fourweeks revision group

Patients will be clinically revised in a 4-weeks basis

Group Type: EXPERIMENTAL

4 weeks revision

Intervention Type: 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.

Eightweeks revision group

Patients will be clinically revised in a 8-weeks basis

Group Type: ACTIVE_COMPARATOR

4 weeks revision

Intervention Type: 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.

Twelveweeks revision group

Patients will be clinically revised in a 12-weeks basis

Group Type: EXPERIMENTAL

4 weeks revision

Intervention Type: 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.

Interventions

4 weeks revision

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Mateo López-Moral, DPM, PhD

Prof. Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clínica Universitaria de Podología de la Universidad Complutense de Madrid

Madrid, Madrid, Spain

Countries

Spain

References

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 Oct 23:112962. doi: 10.1016/j.diabres.2025.112962. Online ahead of print.

Reference Type: DERIVED

PMID: 41139025 (View on PubMed)

Other Identifiers

Diatime_061123

Identifier Type: -

Identifier Source: org_study_id