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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons With Diabetes and Remission: a Three Arm Double Blind Randomized Clinical Trial

Conditions
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Diabetic Foot

Intervention / Treatment
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* Behavioral: 2 weeks revision


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three arms parallel randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Two weeks revision group<br>Patients will be clinically revised in a 2-weeks basis | Behavioral: 2 weeks revision<br>* 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.<br>* Other names: 6 weeks revision;|
| Active Comparator: Four weeks revision group<br>Patients will be clinically revised in a 4-weeks basis | Behavioral: 2 weeks revision<br>* 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.<br>* Other names: 6 weeks revision;|
| Experimental: Six weeks revision group<br>Patients will be clinically revised in a 6-weeks basis | Behavioral: 2 weeks revision<br>* 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.<br>* Other names: 6 weeks revision;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic foot, Reulceration, Prevention