Diabetic Foot Ulcer (DFU), Offloading
Conditions
Brief summary
The goal of this clinical trial is to compare wound healing and foot related outcomes in people with plantar diabetic foot ulcer using Total contact cast (TCC) or Posterior slab cast (PSC). Ninety-nine people with neuropathic DFUs were randomized to use TCC (n=51) or PSC (n=48) together with standard of care for up to 6 months. Researchers will compare rate of healing of ulcer at the end of 6 months, percentage reduction in the surface area, time taken to heal and patient satisfaction. Participants will: * Use TCC or PSC as off-loading till the ulcer heals for upto 6 months * Visit the clinic once every 2 weeks for follow ups when inspection of the wound will be done for wound dressing, wound debridement and infection control when necessary
Interventions
DEVICETotal contact cast
Arm with 51 patients was given total contact cast for offloading DFU
DEVICEPosterior slab cast
Arm with 48 patients were given posterior slab cast for offloading DFU
Sponsors
ILS Hospital, Salt Lake
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* People with diabetes * a single neuropathic plantar DFU * Ulcer belonging to Wagner grade 2 and 3
Exclusion criteria
* Persons with bilateral DFUs * gout * peripheral arterial disease (ABPI \<0.8) * stage 4 and 5 chronic kidney disease \[estimated glomerular filtration rate (eGFR) \<30 ml/min/m2\] * active Charcot arthropathy * history of steroid intake within the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome measure in this study was healing of the ulcer at 6 months. | 6 months | We compared the rate of healing of ulcers and time taken to heal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The secondary outcome measure was the rate of wound size reduction at 4 weeks and patient satisfaction. | 6 Months | Healing rates will be measured by the percentage of ulcers healed or wound closure, based on clinical assessment and standardized wound measurement techniques (i.e., wound area reduction). Patient satisfaction was measured using the Likert scale 1-5 (1= very dissatisfied, 5=very satisfied). |
Countries
India
Outcome results
None listed