Randomised clinical trial to compare total contact casts, healing sandals and a shear-reducing removable boot to heal diabetic foot ulcers

Lawrence A. Lavery, Kevin R. Higgins, Javier La Fontaine, Ruben G. Zamorano, George P. Constantinides, Paul J. Kim

Research output: Contribution to journalArticle

17 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)710-715
Number of pages6
JournalInternational Wound Journal
Volume12
Issue number6
DOIs
StatePublished - Dec 1 2015

Fingerprint

Diabetic Foot
Foot
Randomized Controlled Trials
Ulcer
Foot Ulcer
Ankle Brachial Index
Peripheral Vascular Diseases
Joint Diseases
Immune System Diseases
Osteomyelitis
Wound Healing
Alcoholism
Substance-Related Disorders
Drainage
Oxygen
Wounds and Injuries
Neoplasms

Keywords

  • Amputation
  • Cast
  • Diabetes
  • Infection
  • Off-load
  • Ulceration

ASJC Scopus subject areas

  • Surgery
  • Dermatology

Cite this

Randomised clinical trial to compare total contact casts, healing sandals and a shear-reducing removable boot to heal diabetic foot ulcers. / Lavery, Lawrence A.; Higgins, Kevin R.; La Fontaine, Javier; Zamorano, Ruben G.; Constantinides, George P.; Kim, Paul J.

In: International Wound Journal, Vol. 12, No. 6, 01.12.2015, p. 710-715.

Research output: Contribution to journalArticle

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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.",
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