Diabetic Foot
Conditions
Keywords
Diabetic foot, Reulceration, 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.
Interventions
BEHAVIORAL4 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 4-8-12 weeks revision times could change diabetic foot reulceration rate.
Sponsors
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
No masking is possible to be performed in the planned RCT due to the nature of the intervention (time dependent).
Intervention model description
Three arms parallel randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minor lesion rate | 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. |
| Minor amputation rate | From randomization to first documented diabetic foot ulcer appearance, assessed up to 48 weeks. | Need for minor amputation secondary to ulcer recurrence |
Countries
Spain
Outcome results
None listed