title: Randomised clinical trial to compare total contact casts, healing sandals and a shear-reducing removable boot to heal diabetic foot ulcers.
abstract: The objective of this study was to evaluate the efficacy of three off-loading techniques to heal diabetic foot wounds: total contact casts (TCCs), healing sandals (HSs) and a removable boot with a shear-reducing foot bed (SRB). This was a 12-week, single-blinded randomised clinical trial with three parallel treatment groups of adults with diabetes and a foot ulcer (n = 73). Ulcer healing was defined as full reepithelialisation with no drainage. Diabetic patients with grade UT1A or UT2A forefoot ulcers on the sole of the foot were enrolled. Patients with malignancy, immune-compromising diseases, severe peripheral vascular disease (ankle-brachial index < 0·60 or transcutaneous oxygen < 25 mm/Hg), alcohol or substance abuse within 6 months, untreated osteomyelitis or Charcot arthropathy with residual deformity that would not fit the HS or boot were excluded. In the intent-to-treat analysis, significantly higher proportion of patients were healed in the TCC group (69·6%) compared to those treated with the SRB (22·2%, P < 0·05). There was no difference in the rate of healed ulcers in the HS (44·5%) and TCC groups. Ulcers in the TCC group healed faster than those in the HS group (5·4 ± 2·9 versus 8·9 ± 3·5 weeks, P < 0·02). However, there was no difference in the time to healing in the TCC and SRB groups (6·7 ± 4·3 weeks, P = 0·28). Patients who used HS were significantly more active (4022 ± 4652 steps per day, P < 0·05) than those treated with TCCs (1447 ± 1310) or SRB (1404 ± 1234). It is concluded that patients treated with TCCs had the highest proportion of healed wounds and fastest healing time. The novel shear-reducing walker had the lowest healing and highest rate of attrition during the study.
authors.affiliation: Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, TX, USA.
authors.forename: Lawrence A
authors.initials: LA
authors.lastname: Lavery
authors.affiliation: Private Practice, San Antonio, TX, USA.
authors.forename: Kevin R
authors.initials: KR
authors.lastname: Higgins
authors.affiliation: Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, TX, USA.
authors.forename: Javier
authors.initials: J
authors.lastname: La Fontaine
authors.affiliation: Diabetica Solutions, San Antonio, TX, USA.
authors.forename: Ruben G
authors.initials: RG
authors.lastname: Zamorano
authors.affiliation: Diabetica Solutions, San Antonio, TX, USA.
authors.forename: George P
authors.initials: GP
authors.lastname: Constantinides
authors.affiliation: Department of Plastic Surgery, Georgetown University, Washington, DC, USA.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D002370:Casts, Surgical; D017719:Diabetic Foot / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010865:Pilot Projects; D012775:Shoes; D016037:Single-Blind Method; D016896:Treatment Outcome; D016138:Walking; D016474:Weight-Bearing; D014945:Wound Healing
keywords: Amputation; Cast; Diabetes; Infection; Off-load; Ulceration