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| Name | Class |
|---|---|
| Princess Margaret Hospital, Hong Kong | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Callus debridement | Experimental | Callus debridement which aligns with routine clinical practice of the Princess Margaret Hospital Podiatry Department. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Callus debridement | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plantar pressure (PPP) (unit: kPa) | The maximum or highest pressure within foot | Before treatment, immediately after treatment and 3-4 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure time integral (PTI) (unit: kPa*sec) | The amount of pressure relative to the time that the pressure is present | Before treatment, immediately after treatment and 3-4 weeks post-treatment |
| Peak pressure gradient (PPG) (unit: kPa/cm) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Ka-Kin Ling | Assistant Professor (Clinical) of Orthopaedics & Traumatology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Podiatry Department, Princess Margaret Hospital | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
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Spatial change in pressure around location of the peak pressure
| Before treatment, immediately after treatment and 3-4 weeks post-treatment |
| Forefoot to rearfoot peak pressure ratio (F/R ratio) | Forefoot to rearfoot peak plantar pressure ratio | Before treatment, immediately after treatment and 3-4 weeks post-treatment |
| Foot and Ankle Outcome Score (FAOS) | 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) | Before treatment, 1 week after treatment and 3-4 weeks post-treatment |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |