Diabetic Neuropathies, Plantar Callus
Conditions
Brief summary
Diabetes peripheral neuropathy (DPN) affects up to 50% of the diabetes population. In the diabetic neuropathic foot, it commonly manifests as loss of protective sensation, foot deformity and skin dryness. Alongside with day-to-day weightbearing activities, this can lead to formation of callus over plantar pressure points. Studies have proven that callus formation leads to high plantar pressure and increased risk of diabetic foot ulcers. For podiatrists, diabetic foot screening and treatment is our daily practice. Plantar callus are commonly treated by sharp debridement to relief pressure from the hard skin build up and thus reducing the risk of ulceration. However, the effectiveness of callus sharp debridement is not commonly studied in researches. Only a few studies in the past evaluated the effectiveness of callus treatment by different outcome measurements. Among those studies only 2 were specifically done in diabetic patients, in which one reported results of diabetic neuropathic patients. All the available studies used peak plantar pressure only as their pedobarographic outcome measure. In this study, the treatment effect of podiatric sharp debridement of callus in diabetic neuropathic patients will be evaluated using a range of pedobarographic parameters and Foot and Ankle Outcome Score (FAOS) questionnaire. The immediate and short-term (3-4 weeks) effect of sharp debridement in DPN patients with callus could be quantified. Change in loading pattern could also be analysed based on different areas of the foot.
Interventions
PROCEDURECallus debridement
Eligible patients will be seated on a podiatry couch. Standard skin preparation procedure will be done with 2% Chlorhexidine gluconate in 70% isopropyl cleansing to all areas of feet. The same researcher will perform sharp debridement in all participants to minimize the variance between procedures. The procedure will comply with Infection Control Guideline (Podiatry) . A sterile scalpel handle loaded with a single-use No. 15 blade will be used to carry out sharp debridement using aseptic technique. Hyperkeratotic tissue will be debrided until smooth transition with adjacent skin is achieved and underlying pinkish normal skin is visible. Used scalpel will be unloaded and disposed by a QlickSmart ® BladeFLASK scalpel blade remover.
Sponsors
Princess Margaret Hospital, Hong Kong
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older 2. Active out-patient status in Podiatry department of Princess Margaret Hospital 3. Men and women 4. Ambulatory 5. Diagnosis of type I or II diabetes 6. Failed peripheral neurological assessment (Vibration perception threshold \>25 volts or unable to detect one or more sites of 4-point 10g Semmes-Weinstein monofilament test) 7. Presence of plantar callus 8. Compliance with instructions (in Chinese or english) 9. Ability to read and write (in Chinese or english)
Exclusion criteria
1. Peripheral vascular disease 2. Painful neuropathy 3. Charcot deformity 4. Undergone any form of callus debridement in the past 6 weeks 5. Active foot ulcer 6. Any dermatological condition other than callus that causes hyperkeratosis (e.g. verruca pedis, eczema, tinea pedis) 7. Any musculoskeletal condition that affects balance and gait 8. Allergic to chlorhexidine gluconate or alcohol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak plantar pressure (PPP) (unit: kPa) | Before treatment, immediately after treatment and 3-4 weeks post-treatment | The maximum or highest pressure within foot |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak pressure gradient (PPG) (unit: kPa/cm) | Before treatment, immediately after treatment and 3-4 weeks post-treatment | Spatial change in pressure around location of the peak pressure |
| Pressure time integral (PTI) (unit: kPa*sec) | Before treatment, immediately after treatment and 3-4 weeks post-treatment | The amount of pressure relative to the time that the pressure is present |
| Forefoot to rearfoot peak pressure ratio (F/R ratio) | Before treatment, immediately after treatment and 3-4 weeks post-treatment | Forefoot to rearfoot peak plantar pressure ratio |
| Foot and Ankle Outcome Score (FAOS) | Before treatment, 1 week after treatment and 3-4 weeks post-treatment | Patient-reported outcome measurement (PROM) tool that is calculated using 42 Likert scale questions which are organised into 5 sub-categories: symptoms, pain, activities of daily living (ADL), sports and quality of life (QOL) |
Countries
Hong Kong
Outcome results
None listed