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

Diabetic Foot Clinical Trial

— Diatime  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06143215
• Other study ID #: Diatime_061123
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2024
• Est. completion date: February 15, 2025

Study information

• Verified date: May 2024
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 4-6 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 15, 2025
• Est. primary completion date: January 9, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

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.

Locations

Country	Name	City	State
Spain	Clínica Universitaria de Podología de la Universidad Complutense de Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Minor amputation rate	Need for minor amputation secondary to ulcer recurrence	From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.