Back to resultsImpact of Removable Cast Walker Design on Usability for Patients With Diabetic Foot Ulcers
Primary Purpose
Diabetes Mellitus, Foot Ulcer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
RCW design form
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus
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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Tall RCW
Short RCW with contralateral lift
Arm Description
Outcomes
Primary Outcome Measures
Offloading adherence
Percent of weight bearing activity completed while wearing the RCW
Secondary Outcome Measures
Diabetic Foot Ulcer Healing
Planimetric wound area
Cumulative plantar tissue stress
A measure to account for the interaction between offloading capacity of the RCW and device use
Full Information
NCT ID
NCT05415878
First Posted
June 8, 2022
Last Updated
June 8, 2022
Sponsor
Rosalind Franklin University of Medicine and Science
Collaborators
Manchester Metropolitan University
1. Study Identification
Unique Protocol Identification Number
NCT05415878
Brief Title
Impact of Removable Cast Walker Design on Usability for Patients With Diabetic Foot Ulcers
Official Title
Improving Diabetic Foot Ulcer Offloading: A Pilot Study on the Impact of Removable Cast Walker Design Factors on Usability
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2022 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
August 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rosalind Franklin University of Medicine and Science
Collaborators
Manchester Metropolitan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Foot Ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tall RCW
Arm Type
Other
Arm Title
Short RCW with contralateral lift
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
RCW design form
Intervention Description
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
Primary Outcome Measure Information:
Title
Offloading adherence
Description
Percent of weight bearing activity completed while wearing the RCW
Time Frame
days 0-28
Secondary Outcome Measure Information:
Title
Diabetic Foot Ulcer Healing
Description
Planimetric wound area
Time Frame
each clinical visit during days 0-28
Title
Cumulative plantar tissue stress
Description
A measure to account for the interaction between offloading capacity of the RCW and device use
Time Frame
days 0-28
Other Pre-specified Outcome Measures:
Title
Stability
Description
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)
Title
Correlates of joint pain
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noah J Rosenblatt, PhD
Phone
8475788425
Email
noah.rosenblatt@rosalindfranklin.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Crews, PhD
Email
ryan.crews@rosalindfranklin.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noah J Rosenblatt, PhD
Organizational Affiliation
Rosalind Franklin University of Medicine and Science
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Impact of Removable Cast Walker Design on Usability for Patients With Diabetic Foot Ulcers
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