Clinical trial NCT06357884: Short-term Effect of Podiatric Callus Debridement on Plantar Pressure in Diabetic Neuropathic Patients
Official title: Short-term Effect of Podiatric Callus Debridement on Plantar Pressure in Diabetic Neuropathic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Plantar Callus
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Hong Kong
First posted: 2024-04-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Peak plantar pressure (PPP) (unit: kPa)
timeFrame: Before treatment, immediately after treatment and 3-4 weeks post-treatment
Secondary outcomes:
measure: Pressure time integral (PTI) (unit: kPa*sec)
timeFrame: Before treatment, immediately after treatment and 3-4 weeks post-treatment
measure: Peak pressure gradient (PPG) (unit: kPa/cm)
timeFrame: Before treatment, immediately after treatment and 3-4 weeks post-treatment
measure: Forefoot to rearfoot peak pressure ratio (F/R ratio)
timeFrame: Before treatment, immediately after treatment and 3-4 weeks post-treatment
measure: Foot and Ankle Outcome Score (FAOS)
timeFrame: Before treatment, 1 week after treatment and 3-4 weeks post-treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Podiatry Department, Princess Margaret Hospital
Study officials:
affiliation: Assistant Professor (Clinical) of Orthopaedics & Traumatology
name: Samuel Ka-Kin Ling
role: STUDY_DIRECTOR
References: