Interdigital silicone orthoses

NewsBot · Feb 7, 2014

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Clinical Acceptance, Reasons for Rejection, and Reduction of In-Shoe Peak Pressure with Interdigital Silicone Orthoses
Ulrich Illgne, Tymo Budny, Marc Hoyer, and Hans Henning Wetz
J Am Podiatr Med Assoc 104(1): 30–33, 2014

Background: For several years, confectioned or customized interdigital silicone orthoses have been used to treat toe malformations; however, long-term clinical and biomechanical studies are missing. The aim of this study was to evaluate the biomechanical effects of these orthoses and their clinical acceptance.

Methods: In 2008, 46 patients (30 women and 16 men; average age, 56.8 years) received interdigital silicone orthoses. All of the patients were included in the biomechanical and clinical study. Compliance and acceptance were measured by the Muenster shoe and foot questionnaire, which includes 13 items on pain, activities of daily living, satisfaction, and activity. Mean follow-up was 18 months. Ten feet (eight patients) were chosen by random and underwent pedobarography. One forefoot sensor and two single sensors were attached between the skin and the orthosis. Measurements were performed in-shoe three times with and without the orthosis without removal of the sensors.

Results: Forty-four of the 46 patients (95.7%) were included. At the 18-month investigation, 19 patients no longer used their orthoses, most commonly because of pain and failure of the material. Twenty-two patients regularly used their orthoses (8 h/d on average). In-shoe peak pressure lowered significantly with orthosis use (P < .04). Patients who used the orthoses were mostly satisfied.

Conclusions: Interdigital silicone orthoses reduce in-shoe peak pressure. Patient satisfaction was good. The durability of the material has to be optimized, and manufacturing remains difficult. The effect on ulcer reduction must be evaluated in a large prospective study.
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NewsBot · Mar 22, 2017

Effectiveness of the custom-mold room temperature vulcanizing silicone toe separator on hallux valgus: A prospective, randomized single-blinded controlled trial.
Chadchavalpanichaya N et al
Prosthet Orthot Int. 2017 Mar 1:309364617698518. doi: 10.1177/0309364617698518

BACKGROUND:
Silicone toe separator is considered as a conservative treatment for hallux valgus. The prefabricated toe separator does not fit all. However, effectiveness in prescription of the custom-mold toe separator is still unknown.
OBJECTIVES:
To investigate the effect of using a custom-mold room temperature vulcanizing silicone toe separator to decrease hallux valgus angle and hallux pain. The compliances, complications, and satisfactions of toe separator were also explored.
STUDY DESIGN:
A prospective, randomized single-blinded controlled trial.
METHODS:
A total of 90 patients with a moderate degree of hallux valgus were enrolled in a study at the Foot Clinic, Siriraj Hospital, Thailand. Patients were randomized into two groups; the study group was prescribed a custom-mold room temperature vulcanizing silicone toe separator for 6 h per night for 12 months. Patients in both groups received proper foot care and shoes and were permitted to continue drug treatment.
RESULTS:
In total, 40 patients in the study group and 39 patients in the control group completed the study. The hallux valgus angle was obtained through radiographic measurement. At month 12, both groups had significant differences in mean hallux valgus angle with a decrease of 3.3° ± 2.4° for the study group and increase of 1.9° ± 1.9° for the control group. There were statistically significant differences of hallux valgus angle between the two groups ( p < 0.05) at the end of the study. Hallux pain was decreased in the study group.
CONCLUSION:
A custom-mold room temperature vulcanizing silicone toe separator can decrease hallux valgus angle and pain with no serious complications. Clinical relevance The custom-mold room temperature vulcanizing silicone toe separator for treatment of hallux valgus reduces deformity and hallux pain.
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NewsBot · Jan 31, 2024

The effects of the use of customized silicone digital orthoses on pre-ulcerative lesions and plantar pressure during walking in people with diabetic neuropathy: A study protocol for a randomized controlled trial
Maria L S Lucoveis et al
Contemp Clin Trials Commun. 2023 Dec 23

Background: People with diabetes and diabetic peripheral neuropathy (DPN) often develop calluses due to toe misalignment and increased plantar pressure. Untreated, these issues can progress into ulcers, making early intervention crucial. This trial protocol aims to evaluate the efficacy and safety of customized silicone digital orthoses in preventing ulcers, pre-ulcerative lesions, and peak pressure during gait in people with DPN.

Methods: In this superiority randomized controlled parallel trial with single-blind assessment, 60 participants will be allocated to the control group (CG) or the intervention group (IG). The CG will receive specialized nurse-administered foot care, including callus removal, nail care guidance, and self-care education. The IG will receive the same care plus a customized silicone orthosis for toe realignment for 6 months. Assessments will occur at baseline and 3 and 6 months for the primary outcomes (pre-ulcerative lesions and ulcer incidence) and secondary outcomes (pressure distribution, foot function and health, quality of life, safety, and comfort). Two-way ANOVAs (p < .05) will assess group, time, and group by time effects following an intention-to-treat approach.

Conclusion: Although recommended for foot ulcer prevention, custom silicone orthosis adoption remains limited due to the low certainty of evidence. This trial seeks to provide more consistent evidence for the use of toe orthoses in preventing callus and ulcer formation for individuals with DPN.
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