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Completed

NCT Number: NCT06143215

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Universitaria de Podología de la Universidad Complutense de Madrid

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Minor lesion rate

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

    Defined as non ulcerative lesions of the skin on the plantar aspect of the foot and included abundant callus, hemorrhage, or a blister.

  2. Minor amputation rate

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

    Need for minor amputation secondary to ulcer recurrence

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study 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

Acronym: Diatime

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 22, 2023
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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