Short-term Effect of Podiatric Callus Debridement on Plantar Pressure in Diabetic Neuropathic Patients

NCT06357884 | Completed

• 1 other identifier: CREC2023.572
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathies; Plantar Callus

Outcome Measures

Primary Outcomes (1)

• Peak plantar pressure (PPP) (unit: kPa)

  The maximum or highest pressure within foot

  Before treatment, immediately after treatment and 3-4 weeks post-treatment

Secondary Outcomes (4)

• Pressure time integral (PTI) (unit: kPa*sec)

  Before treatment, immediately after treatment and 3-4 weeks post-treatment

• Peak pressure gradient (PPG) (unit: kPa/cm)

  Before treatment, immediately after treatment and 3-4 weeks post-treatment

• Forefoot to rearfoot peak pressure ratio (F/R ratio)

  Before treatment, immediately after treatment and 3-4 weeks post-treatment

• Foot and Ankle Outcome Score (FAOS)

  Before treatment, 1 week after treatment and 3-4 weeks post-treatment

Study Arms (1)

Callus debridement

EXPERIMENTAL

Callus debridement which aligns with routine clinical practice of the Princess Margaret Hospital Podiatry Department.

Procedure: Callus debridement

Interventions

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.

Callus debridement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Active out-patient status in Podiatry department of Princess Margaret Hospital
• Men and women
• Ambulatory
• Diagnosis of type I or II diabetes
• 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)
• Presence of plantar callus
• Compliance with instructions (in Chinese or english)
• Ability to read and write (in Chinese or english)

You may not qualify if:

• Peripheral vascular disease
• Painful neuropathy
• Charcot deformity
• Undergone any form of callus debridement in the past 6 weeks
• Active foot ulcer
• Any dermatological condition other than callus that causes hyperkeratosis (e.g. verruca pedis, eczema, tinea pedis)
• Any musculoskeletal condition that affects balance and gait
• Allergic to chlorhexidine gluconate or alcohol

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Princess Margaret Hospital, Hong Kong: collaborator

Study Sites (1)

Podiatry Department, Princess Margaret Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Samuel Ka-Kin Ling

  Assistant Professor (Clinical) of Orthopaedics & Traumatology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Student

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 10, 2024
• Study Start: February 23, 2024
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)