Diabetes Mellitus, Foot Ulcer
Conditions
Brief 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.
Interventions
DEVICERCW design form
Tall 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
Sponsors
Rosalind Franklin University of Medicine and Science
Manchester Metropolitan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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) * gait/balance disturbance not attributable to diabetes (e.g. neuromuscular disease or cerebrovascular vascular accident) * current or previous (within past year) use of an ankle-high RCW or of a contralateral lift to offset an RCW-induced LLD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Offloading adherence | days 0-28 | Percent of weight bearing activity completed while wearing the RCW |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetic Foot Ulcer Healing | each clinical visit during days 0-28 | Planimetric wound area |
| Cumulative plantar tissue stress | days 0-28 | A measure to account for the interaction between offloading capacity of the RCW and device use |
Countries
United States
Contacts
CONTACTNoah J Rosenblatt, PhD
CONTACTRyan Crews, PhD
PRINCIPAL_INVESTIGATORNoah J Rosenblatt, PhD
Rosalind Franklin University of Medicine and Science
Outcome results
None listed