protocolSection identificationModule nctId: NCT06357884, orgStudyIdInfo id: CREC2023.572, briefTitle: Short-term Effect of Podiatric Callus Debridement on Plantar Pressure in Diabetic Neuropathic Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-23, primaryCompletionDateStruct date: 2024-04-20, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-04-10, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, collaborators name: Princess Margaret Hospital, Hong Kong, descriptionModule briefSummary: 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., conditionsModule conditions: Diabetic Neuropathies, conditions: Plantar Callus, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: Callus debridement, outcomesModule primaryOutcomes measure: Peak plantar pressure (PPP) (unit: kPa), secondaryOutcomes measure: Pressure time integral (PTI) (unit: kPa*sec), secondaryOutcomes measure: Peak pressure gradient (PPG) (unit: kPa/cm), secondaryOutcomes measure: Forefoot to rearfoot peak pressure ratio (F/R ratio), secondaryOutcomes measure: Foot and Ankle Outcome Score (FAOS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Podiatry Department, Princess Margaret Hospital, status: RECRUITING, city: Hong Kong, country: Hong Kong, contacts name: Joanne Tze Yan Lai, role: CONTACT, phone: 29903901, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False