Impact of Removable Cast Walker Design on Usability for Patients With Diabetic Foot Ulcers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRosalind Franklin University of Medicine and Science
About this trial
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
This trial does not accept healthy volunteersQualifiers
presence of a full thickness plantar (forefoot) diabetic foot ulcer ≥1cm2 that is being treated on an outpatient basis with a University of Texas wound classification of 1A-C or 2 A-C;
self-reported ability to walk for at least two continuous minutes at a self-selected speed
confirmation of the presence of diabetic peripheral neuropathy as identified by failure to detect a 10 gram Semmes Weinstein Monofilament on either foot at one of four sites tested (1st, 3rd, 5th metatarsal heads, and plantar surface of hallux) OR a vibration perception threshold value of 25 or more at either hallux.
Disqualifiers
lower extremity amputation more proximal than transmetatarsal on either limb
chronic kidney disease stage 4 or higher (i.e., currently undergoing dialysis or eGFR<30 within last 60 days)
active Charcot neuroarthropathy
severe peripheral arterial disease (non-palpable pulse at posterior tibia and dorsalis pedis arteries, and an ankle brachial index<0.7)
Trial design
Design model
Parallel
Treatments tested in this trial
RCW design form
DeviceTall RCW= a knee high removable cast walker with an offloading insole Short RCW= an ankle high (extending up the leg just past the ankle) removable cast walker with an offloading insole, paired with an external shoe lift to be used with a diabetic shoe on the contralateral limb
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Tall RCWOther 1 intervention
Group B: Short RCW with contralateral liftOther 1 intervention
Trial outcomes
Primary outcomes
1
Offloading adherence
Percent of weight bearing activity completed while wearing the RCW
Time frame
days 0-28Secondary outcomes
1
Diabetic Foot Ulcer Healing
Planimetric wound area
Time frame
each clinical visit during days 0-282
Cumulative plantar tissue stress
A measure to account for the interaction between offloading capacity of the RCW and device use
Time frame
days 0-28Other outcomes
1
Stability
three separate measures taken during walking and standing (local divergence exponent of he trunk; motor equivalent index during small standing perturbations; and posterior stepping threshold for large perturbations while standing)
Time frame
follow up visit (32-38 days after baseline)2
Correlates of joint pain
Four separate biomechanical measures related to back, hip and knee pain taken during walking in a motion capture lab (peak pelvic obliquity; peak pelvic tilt; ground reaction force transience; and rate of grand reaction force loading)
Time frame
follow up visit (32-38 days after baseline)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Rosalind Franklin University of Medicine and Science
Lead sponsor
Manchester Metropolitan University
Collaborator
Source ClinicalTrials.gov