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

NCT06143215 | Completed

• 1 other identifier: Diatime_061123
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Foot

Keywords

Diabetic foot; Reulceration; Prevention

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Minor lesion rate

  From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.

• Minor amputation rate

  From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.

Study Arms (3)

Fourweeks revision group

EXPERIMENTAL

Patients will be clinically revised in a 4-weeks basis

Behavioral: 4 weeks revision

Eightweeks revision group

ACTIVE COMPARATOR

Patients will be clinically revised in a 8-weeks basis

Behavioral: 4 weeks revision

Twelveweeks revision group

EXPERIMENTAL

Patients will be clinically revised in a 12-weeks basis

Behavioral: 4 weeks revision

Interventions

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.

Eightweeks revision group; Fourweeks revision group; Twelveweeks revision group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Active Charcot foot process.
• Conditions other than diabetes also associated with foot ulcers were excluded from the study as well.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Clínica Universitaria de Podología de la Universidad Complutense de Madrid

Madrid, Madrid, 28040, Spain

Location

Related Publications (1)

• 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.

  PMID: 41139025 DERIVED

MeSH Terms

Conditions

Diabetic Foot

Interventions

Second-Look Surgery

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking is possible to be performed in the planned RCT due to the nature of the intervention (time dependent).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr

Model Details: Three arms parallel randomized clinical trial

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: November 22, 2023
• Study Start: January 10, 2024
• Primary Completion: December 9, 2024
• Study Completion: February 15, 2025
• Last Updated: March 19, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)