Podiatry Department, Princess Margaret Hospital
Hong Kong
NCT Number: NCT06357884
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Hong Kong
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Before treatment, immediately after treatment and 3-4 weeks post-treatment
The maximum or highest pressure within foot
Time frame: Before treatment, immediately after treatment and 3-4 weeks post-treatment
The amount of pressure relative to the time that the pressure is present
Time frame: Before treatment, immediately after treatment and 3-4 weeks post-treatment
Spatial change in pressure around location of the peak pressure
Time frame: Before treatment, immediately after treatment and 3-4 weeks post-treatment
Forefoot to rearfoot peak plantar pressure ratio
Time frame: 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)
Chinese University of Hong Kong
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06292962
Diabetes Complications, Diabetes Mellitus
Lahore, Pakistan
View Trial DetailsNCT06482827
Diabetes Complications, Diabetes Mellitus
Hamilton, Ontario, Canada
View Trial DetailsNCT05683106
Cardiovascular Diseases, Diabetes Complications
São Paulo, Brazil
View Trial DetailsNCT06025422
Cardiovascular Diseases, Diabetes Complications
Leicester, Leicestershire, United Kingdom
View Trial Details