Efficacy of injected liquid silicone in the diabetic foot to reduce risk factors for ulceration: a randomized double-blind placebo-controlled trial.

Abstract

Abbreviations: ABPI, ankle-brachial pressure index; CVA, cerebrovascular accident; NDS, neuropathy disability score; VPT, vibration perception threshold.A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances. Efficacy of Injected Liquid Silicone in the Diabetic Foot to Reduce Risk Factors for UlcerationA randomized double-blind placebo-controlled trialOBJECTIVE -To investigate the effectiveness of injecting liquid silicone in the diabetic foot to reduce risk factors for ulceration in a randomized double-blind placebo-controlled trial. RESEARCH DESIGN AND METHODS-A total of 28 diabetic neuropathic patients without peripheral vascular disease were randomized to active treatment with 6 injections of 0.2 ml liquid silicone in the plantar surface of the foot or to treatment with an equal volume of saline (placebo). No significant differences were evident regarding age or neuropathy status between the 2 groups. All injections were under the metatarsal heads at sites of calluses or high pressures. Barefoot plantar pressures (pedobarography) and plantar tissue thickness under the metatarsal heads (Planscan ultrasound device) were measured at baseline and at 3, 6, and 12 months after the first injection. Injection sites were photographed at all stages, and callus formation was scored as a change from baseline. Throughout the study, patients were treated by the same podiatrist for all podiatry treatment.RESULTS -Patients who received silicone treatment had significantly increased plantar tissue thickness at injection sites compared with the placebo group (1.8 vs. 0.1 mm) (P Ͻ 0.0001) and correspondingly significantly decreased plantar pressures (Ϫ232 vs. Ϫ25 kPa) (P Ͻ 0.05) at 3 months, with similar results at 6 and 12 months. A trend was noted toward a reduction of callus formation in the silicone-treated group compared with no change in the placebo group. E m e r g i n g T r e a t m e n t s a n d T e c h n o l o g i e s CONCLUSIONS

The diabetic foot: from art to science. The 18th Camillo Golgi lecture

“…A randomised, double-blind trial of injected liquid silicone in the diabetic foot was later carried out in an attempt to confirm these earlier observations. Van Schie et al [67] confirmed that silicone injections were associated with increased sub-metatarsal head soft-tissue thickness, decreases in foot pressures and reduced callus formation. Thus, the use of an "injectable orthosis" might well be beneficial in high-risk patients.…”

Plantar Tissue Thickness Is Related to Peak Plantar Pressure in the High-Risk Diabetic Foot

“…The use of the Planscan might prove to be a useful alternative tool to study and follow up the diabetic patients who are at risk of foot ulceration; however, this needs to be confirmed by prospective analysis of the patients involved in this study. Once a patient is found to have reduced plantar tissue thickness, then methods to increase tissue thickness or other methods of foot protection can be applied (19).…”

“…When addressing the area of interest for pressure analysis at each MTH, the cursor was used to select a circular MTH region; at no time was there any overlap among individual MTH pressure regions. Areas were carefully selected as previously described (19).…”

Benefits, Challenges, and Potential Utility of a Gait Database for Diabetes Patients

“…This allows interventional therapies to be employed to reduce pressures in the identified areas, often in the form of specialized footwear or orthoses. 15,16 Other methods shown to reduce plantar pressures include: surgery to increase dorsiflexion range 17 or replace depleted soft tissue; 18 as well walking with shorter step lengths. 19 There is some discussion on whether vertical plantar pressures alone are a strong indicator of ulceration.…”