This Research Hypothesizes That the Use of a Rigid Rocker Sole Reduces the Recurrence Rate of Diabetic Foot Ulcers in Patients With Peripheral Neuropathy.

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.

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot; Diabetic Foot Ulcer
• Intervention / Treatment: Device: Rigid Rocker Sole Footwear; Device: Therapeutic Footwear

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Clínica Universitaria de podología de la Universidad Complutense de Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Rigid rocker sole footwear	Device: Rigid Rocker Sole Footwear
Active Comparator: Control Group; Therapeutic footwear	Device: Therapeutic Footwear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of diabetic foot ulcer	The Wagner system assesses ulcer depth and the presence of osteomyelitis or gangrene using the following grades: grade 0 (pre- or post-ulcerative lesion), grade 1 (partial/full-thickness ulcer), grade 2 (probing to tendon or capsule), grade 3 (deep with osteitis), grade 4 (partial foot gangrene) and grade 5 (whole foot gangrene	through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ankle Joint movility	The ankle joint is examined in the neutral position, with the patient prone; a vertical line is marked on the patient's skin from heel to midcalf, and the maxi- mum range of dorsiflexion in passive motion is mea- sured in degrees with a goniometer. The normal value for the ankle joint is a mobility >90° of dorsi- flexion.	through study completion, an average of 6 months
Mobility of the First metatarsal Joint	Is examined with the patient in the supine position, and a horizontal line is drawn from the big toe to the heel. The maximum range of pas- sive dorsiflexion is recorded. The normal range of joint mobility is >65° at rest and 30° when the patient is standing.	through study completion, an average of 6 months
Subtalar Joint Movements	(inversion and eversion) are examined with the patient in a prone position, holding the calcaneus with one hand and the neck of the astragalus with the thumb and index finger of the other hand. Holding the astragalus rather than the tibia isolated the s	through study completion, an average of 6 months
IPAQ (International Physical Activity Questionnaires)	The purpose of the International Physical Activity Questionnaires (IPAQ) is to provide a set of well-developed instruments that can be used internationally to obtain comparable estimates of physical activity. There are two versions of the questionnaire. The short version is suitable for use in national and regional surveillance systems and the long version provide more detailed information often required in research work or for evaluation purposes.	through study completion, an average of 6 months
Foot Type	The validated protocol of the Foot Posture Index-6 involves the rating of three criteria in the rearfoot: Talar head palpation,Supra- and infra-lateral malleolar curvature and Calcaneal frontal plane position. In addition, there are three criteria on the forefoot: Prominence in the region of the talonavicular joint (TNJ), Congruence of the medial longitudinal arch (MLA), Abduction/adduction of the forefoot on the rearfoot. Each item is graded by a five-point Likert-type, from -2 to +2: 0 for neutral, with a minimum score of -2 for clear signs of supination, and +2 for positive signs of pronation. The final FPI-6 score will be a whole number between -12 and +12. A total FPI-6 score between 0 and +5 indicates a neutral foot, a score of above +6 indicates a pronated or highly pronated foot, and a score between -1 and -12 indicates a supinated or highly supinated foot.	through study completion, an average of 6 months
Deformities	Forefoot deformities were considered when the foot presented any of the following: hallux valgus, Tailor's bunion; toe contractures (hammer-toe, claw-toe or mallet-toe deformities); subluxation or dislocation of the metatarsophalangeal joints (overlapped toe and prominent metatarsal heads).	through study completion, an average of 6 months
Ankle - Brachial Index (ABI)	Were assessed by the same experienced podiatrist using a manual 8 MHz Doppler (Doppler II, Huntleigh Healthcare Ltd, South Glamorgan, UK), and the toe systolic pressure was taken with a digital plethysmography (Systoe, Atys Medical, Quermed, Madrid). The dorsalis pedis artery was used for recording ankle values. The ABI were calculated with the equations of the ankle pressure readings divided by the highest brachial reading between the right and left arms. We considered Peripheral Arterial Disease to have an ABI value less than 0.9; normal ABI values were between 0.9 and 1.39, and an ABI value ≥1.4 was considered poorly compressible vessels related to medial arterial calcification in distal arteries.	through study completion, an average of 6 months
Sensorimotor neuropathy	Sensorimotor neuropathy was diagnosed by evaluation using a Semmes-Weinstein 5.07/10 g monofilament and a biothesiometer (both from Novalab Iberica, Madrid, Spain). Patients who did not feel 1 of the 2 tests were diagnosed with neuropathy.	through study completion, an average of 6 months
Physical Activity Questionnaire	Measurements about time of use of footwear either at home or outdoor. Normal value ranges are: never, 1 day per week, 1 to 3 day per week, 4 to 5 days per week and 6 to 7 days per week. And measurements about how many hours per day the patient wear the footwear, the normal value ranges are: less than 1 hour, 1 to 3 hours per day, 4 to 7 hours per day, 8 to 11 hours per day and more than 12 hours per day.	through study completion, an average of 6 months
Toe - Brachial Index (TBI)	Were assessed by the same experienced podiatrist using a manual 8 MHz Doppler (Doppler II, Huntleigh Healthcare Ltd, South Glamorgan, UK), and the toe systolic pressure was taken with a digital plethysmography (Systoe, Atys Medical, Quermed, Madrid). The ABI and the TBI were calculated with the equations of the ankle or toe pressure readings divided by the highest brachial reading between the right and left arms. We considered PAD to have a TBI value less than 0.7; normal TBI values were between 0.7 and 0.99, and TBI ≥ 1 was considered distal arteries calcification.	through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2016
• Primary Completion (Actual): December 10, 2017
• Study Completion (Actual): May 10, 2018

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (Estimate): December 19, 2016

Study Record Updates

• Last Update Posted (Actual): May 16, 2018
• Last Update Submitted That Met QC Criteria: May 10, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer
• Other Study ID Numbers: UComplutenseMadrid