Impact of Removable Cast Walker Design on Usability for Patients With Diabetic Foot Ulcers

Last updated: June 8, 2022
Sponsor: Rosalind Franklin University of Medicine and Science
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Ulcers

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT05415878
DK131303
  • Ages > 18
  • All Genders

Study Summary

Within their lifetime, over 30% of people living with diabetes will develop a diabetic foot ulcer (DFU), many of which will never heal and may require amputation. Removable cast walkers (RCWs) are commonly prescribed to offload (treat) DFUs. While RCWs are prescribed to be worn during all weight bearing activities, adherence to this prescription is low. This is a serious concern given that low adherence predicts poor DFU healing. This study will provide pilot/feasibility data to inform a larger clinical trial to evaluate the impact of existing RCW designs on adherence and DFU healing. We will also quantify the effect of RCW form on biomechanical and self-reported measures related to usability. Our working hypothesis is that healing outcomes with a given RCW will be predicted by biomechanical and self-reported measures of RCW usability, with the predictive relationship partly explained by the effect of these measures on adherence.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • presence of a full thickness plantar (forefoot) diabetic foot ulcer ≥1cm2 that isbeing treated on an outpatient basis with a University of Texas wound classificationof 1A-C or 2 A-C;
  • self-reported ability to walk for at least two continuous minutes at a self-selectedspeed
  • confirmation of the presence of diabetic peripheral neuropathy as identified byfailure to detect a 10 gram Semmes Weinstein Monofilament on either foot at one offour sites tested (1st, 3rd, 5th metatarsal heads, and plantar surface of hallux) OR avibration perception threshold value of 25 or more at either hallux.

Exclusion

Exclusion Criteria:

  • lower extremity amputation more proximal than transmetatarsal on either limb
  • chronic kidney disease stage 4 or higher (i.e., currently undergoing dialysis oreGFR<30 within last 60 days)
  • active Charcot neuroarthropathy
  • severe peripheral arterial disease (non-palpable pulse at posterior tibia and dorsalispedis arteries, and an ankle brachial index<0.7)
  • gait/balance disturbance not attributable to diabetes (e.g. neuromuscular disease orcerebrovascular vascular accident)
  • current or previous (within past year) use of an ankle-high RCW or of a contralaterallift to offset an RCW-induced LLD

Study Design

Total Participants: 40
Study Start date:
October 01, 2022
Estimated Completion Date:
August 01, 2025