Clinical trial NCT06143215: Clinical Efficacy of Different Revision Times in the Reulceration Rate in Persons with Diabetes and Remission
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Keywords: Diabetic foot
Reulceration
Prevention
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2023-11-22
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three arms parallel randomized clinical trial
Primary purpose: PREVENTION

Brief 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 4-12 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recurrence rate
timeFrame: From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.
Secondary outcomes:
measure: Minor lesion rate
timeFrame: From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.
measure: Minor amputation rate
timeFrame: From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clínica Universitaria de Podología de la Universidad Complutense de Madrid
Study officials:
References: