No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Rosalind Franklin University of Medicine and Science · Other
Who this trial is looking for
This trial is looking for people with diabetic foot ulcers who can walk for a short time. Participants will try out a specific type of walker designed to help with their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I have a diabetic foot ulcer that is being treated and is at least 1cm2 in size.
I can walk continuously for at least two minutes.
I have been diagnosed with diabetic peripheral neuropathy.
You may not be able to join if
I have had an amputation above the toes.
I have chronic kidney disease stage 4 or higher.
I have active Charcot neuroarthropathy.
I have severe peripheral arterial disease.
I have a gait or balance problem not caused by diabetes.
I have used a removable cast walker or related device in the past year.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 adh…
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.
Trial Locations
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Eligibility Criteria
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…
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
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