Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons With Diabetes and Remission (Diatime)

November 15, 2023 updated by: Mateo López Moral, Universidad Complutense de Madrid

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 4-6 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 two weeks.
  • Group 2: patients revised every four weeks.
  • Group 3: patients revised every six weeks.

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Clínica Universitaria de Podología de la Universidad Complutense de Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Two weeks revision group
Patients will be clinically revised in a 2-weeks basis
Behavioral: 2 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 2-4-6 weeks revision times could change diabetic foot reulceration rate.
Other Names:
  • 6 weeks revision
Active Comparator: Four weeks revision group
Patients will be clinically revised in a 4-weeks basis
Behavioral: 2 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 2-4-6 weeks revision times could change diabetic foot reulceration rate.
Other Names:
  • 6 weeks revision
Experimental: Six weeks revision group
Patients will be clinically revised in a 6-weeks basis
Behavioral: 2 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 2-4-6 weeks revision times could change diabetic foot reulceration rate.
Other Names:
  • 6 weeks revision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
Need for minor amputation secondary to ulcer recurrence
From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 6, 2023

Primary Completion (Estimated)

January 9, 2025

Study Completion (Estimated)

February 15, 2025

Study Registration Dates

First Submitted

November 10, 2023

First Submitted That Met QC Criteria

November 15, 2023

First Posted (Estimated)

November 22, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Diatime_061123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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