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

Universidad Complutense de Madrid

Status: Completed

Conditions: Diabetic Foot

Treatments: Behavioral: 4 weeks revision

Study type: Interventional

Funder types: Other

Identifiers

NCT06143215

Diatime_061123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 3 patient groups

Fourweeks revision group

Experimental group

Description:

Patients will be clinically revised in a 4-weeks basis

Treatment:

Behavioral: 4 weeks revision

Eightweeks revision group

Active Comparator group

Description:

Patients will be clinically revised in a 8-weeks basis

Treatment:

Behavioral: 4 weeks revision

Twelveweeks revision group

Experimental group

Description:

Patients will be clinically revised in a 12-weeks basis

Treatment:

Behavioral: 4 weeks revision