Trial reportFoot & ankle international2012
Botulinum toxin effects on gasatrocnemius strength and plantar pressure in diabetics with peripheral neuropathy and forefoot ulceration.
Trial report in Foot & ankle international, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.
- Effectiveness of offloading interventions to heal foot ulcers in persons with diabetes: a systematic review.Diabetes/metabolism research and reviews · 2020Pooled it
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Authors and funding
7 authors at 1 institution in 1 country.
Funding
Abstract
backgroundHigh forefoot plantar pressure is associated with plantar ulcers in people with diabetes and peripheral neuropathy. The purpose of this pilot study was to determine the safety and efficacy of botulinum toxin A injected into the gastrocnemius-soleus muscles to reduce muscle strength and plantar pressure.
methodsThis double blind, randomized clinical trial studied 17 people with diabetes mellitus, peripheral neuropathy and a forefoot plantar ulcer. Subjects were randomized into one of three groups receiving gastrocnemius-soleus muscle injections on the involved side with; 1) Saline (n = 5, weight =99± 21 kg), 2) 200-units of Botox® (n = 7, weight = 101± 5 kg), or 3) 300-units of Botox® (n = 5, weight = 129± 22 kg). Botox® dose was converted to units/kg, the majority received between 1.9 and 2.4 units/kg (n = 11) and one 3.2 units/kg. Plantarflexor peak torque and forefoot peak plantar pressure were quantified prior and 2 weeks post-injection.
resultsThere were no complications from the injections. Plantarflexor peak torque on the involved side increased in the placebo and 300 groups (3± 4 Nm and 6± 10 Nm, respectively) and decreased -8± 11 Nm in the 200 group. There was no relationship between units/kg of Botox® for each subject and change in plantarflexor peak torque. Forefoot peak plantar pressure did not change in the placebo and 300 groups (0± 11 and 0± 5 N/cm(2), respectively) and decreased -4± 16 N/cm2 (4%) for the 200 group.
conclusionThere were no adverse events associated with the Botox® injections. This study was unable to determine the dose to consistently reduce plantarflexor strength and forefoot plantar pressure. Additional research is needed to investigate diabetes mellitus specific physiological changes and their impact of BoNT-A effectiveness in order to guide appropriate dosing.
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