Clinical trial NCT02995863: This Research Hypothesizes That the Use of a Rigid Rocker Sole Reduces the Recurrence Rate of Diabetic Foot Ulcers in Patients With Peripheral Neuropathy.
Official title: Clinical Efficacy of Therapeutic Footwear With a Rigid Rocker Sole in the Prevention of Reulceration in Patients With Diabetes Mellitus and Diabetic Polineuropathy: a Prospective and Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot
Diabetic Foot Ulcer
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research presents a randomized clinical trial which analyzes the efficacy of a rigid rocker sole in the reduction of the recurrence rate of plantar ulcers in diabetic foot patients. The hypothesis of the research is the use of a rigid rocker sole reduces the recurrence rate of diabetic foot ulcers in patients with peripheral neuropathy.


Eligibility criteria: Inclusion Criteria:

* Type 1 or 2 diabetic patients regardless of the pharmacotherapy that they receive.
* Adult patients of both sexes.
* Peripheral neuropathy patients.
* Patients without wounds or ulcers at the examination time.
* Patients with a foot ulcers history.
* Patients with or without minor amputation prior to the inclusion time in the present study.
* Patients who don´t need gait support mechanisms such as walking sticks, crutches, splints or any other devices which interferes with the autonomous development of the gait.

Exclusion Criteria:

* Patients with mayor amputation.
* Patients with rheumatic disease that affect the feet.
* Patients with peripheral neuropathy of different etiology to Diabetes mellitus.
* Patients with several critical ischemia criteria, defined by TACS II guideline.

Primary outcomes:
measure: Presence of diabetic foot ulcer
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Ankle Joint movility
timeFrame: through study completion, an average of 6 months
measure: Mobility of the First metatarsal Joint
timeFrame: through study completion, an average of 6 months
measure: Subtalar Joint Movements
timeFrame: through study completion, an average of 6 months
measure: IPAQ (International Physical Activity Questionnaires)
timeFrame: through study completion, an average of 6 months
measure: Foot Type
timeFrame: through study completion, an average of 6 months
measure: Deformities
timeFrame: through study completion, an average of 6 months
measure: Ankle - Brachial Index (ABI)
timeFrame: through study completion, an average of 6 months
measure: Sensorimotor neuropathy
timeFrame: through study completion, an average of 6 months
measure: Physical Activity Questionnaire
timeFrame: through study completion, an average of 6 months
measure: Toe - Brachial Index (TBI)
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clínica Universitaria de Podología de la Universidad Complutense de Madrid
Study officials:
References:
citation: Lopez-Moral M, Lazaro-Martinez JL, Garcia-Morales E, Garcia-Alvarez Y, Alvaro-Afonso FJ, Molines-Barroso RJ. Clinical efficacy of therapeutic footwear with a rigid rocker sole in the prevention of recurrence in patients with diabetes mellitus and diabetic polineuropathy: A randomized clinical trial. PLoS One. 2019 Jul 11;14(7):e0219537. doi: 10.1371/journal.pone.0219537. eCollection 2019.