Clinical trial NCT05683106: Effects of Customized Silicone Digital Orthoses in People With Diabetic Neuropathy
Official title: Effects of the Use of Customized Silicone Digital Orthoses on Pre-ulcerative Lesions and Plantar Pressure During Walking in People With Diabetic Neuropathy: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetic Neuropathies
Keywords: Diabetes Mellitus
Diabetic foot
Plantar pressure
Orthosis digital
quality of life
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2023-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment
Primary purpose: PREVENTION

Brief summary: The present study aims to evaluate the efficacy and safety of the use of customized silicone digital orthoses for six months in the distribution of plantar pressure, in the reduction of pre-ulcerative lesions and plantar ulcers in the forefoot, foot deformities, quality of life and foot health and functionality in people with diabetes and neuropathy with risk category 2 and 3 for ulcers, according to the International Working Group on Diabetic Foot.

Detailed description: The present study aims to evaluate the effects and safety of the use of customized silicone digital orthoses for six months in the plantar pressure distribution during gait, in the reduction of pre-ulcerative lesions and plantar ulcers at forefoot, in functional balance, foot deformities, quality of life and foot health and functionality in people with diabetes and and diabetic neuropathy with risk category 2 and 3, according to the International Working Group on Diabetic Foot.

The sample will consist of 60 participants, who will be randomly allocated, in a randomized controlled clinical trial, in the control or intervention groups and evaluated at baseline, 3 and 6 months of follow up. The assessment includes (1) classification of the risk of foot ulceration, (2) analysis of plantar pressure during gait, (3) quality of life, (4) foot deformities, (5) pre-ulcerative lesions, (6) functionality and general health of the feet.

The hypothesis of this study is that the intervention group will present a reduction in the peak pressures during gait, a reduction in hyperkeratosis at forefoot, a reduction in the incidence and recurrence of forefoot ulcerations, and improved quality of life and in the functionality and health of the foot, when compared to the control group after six months of use of silicone digital orthoses.

Eligibility criteria: Inclusion Criteria:

* Diagnosed type 1 or 2 diabetes, with diabetic peripheral neuropathy confirmed by loss of sensitivity measured by 10 g Semmes-Weinstein monofilament or 128Hz tuning fork and by the fuzzy score (www.usp.br/labimph/fuzzy);
* Presence of 1 or more deformities at the forefoot region (claw toes, hammer toes, mallet toes, overlapping toes, hallux valgus, prominence of the metatarsal heads or reduction/displacement of the fat pad);
* Ability to walk independently with or without the aid of a walking device;

Exclusion Criteria:

* Presence of other diagnosed neurological diseases;
* Presence of dementia or inability to give consistent information;
* Presence of major vascular complications;
* Receiving any physiotherapy intervention;
* Major vascular complications (ischemia)
* Presence of an active ulcer at the time of baseline assessment;
* Major amputations;
* Minor amputations, except toes.

Primary outcomes:
measure: Change from Baseline Pre-ulcerative lesions and ulcers at 12 and 24 weeks
timeFrame: 12-weeks, 24-weeks
Secondary outcomes:
measure: Change from Baseline Dynamic Plantar Pressure Distribution during gait at 12 and 24 weeks
timeFrame: 12 and 24 weeks
measure: Change from Baseline Foot health and functionality at 12 and 24 weeks
timeFrame: 12 and 24 weeks
measure: Change from baseline of the Quality of life at 12 and 24 weeks
timeFrame: 12 and 24 weeks
measure: Change from Baseline Safety at 12 weeks
timeFrame: 12 weeks
measure: Change from Baseline Satisfaction at 12 weeks
timeFrame: 12 weeks
measure: Change from Baseline Comfort at 12 weeks
timeFrame: 12-weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Stay Care Clinica
state: SP
Study officials:
affiliation: Associate Professor at São Paulo University
name: Isabel C Sacco, PhD
role: PRINCIPAL_INVESTIGATOR
References: