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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Neuropathies; Plantar Callus
• Intervention / Treatment: Procedure: Callus debridement

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joanne Tze Yan Lai; Phone Number: 29903901; Email: 1155030365@link.cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Podiatry Department, Princess Margaret Hospital
    • Contact: Joanne Tze Yan Lai; Phone Number: 29903901

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Procedure: Callus debridement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Princess Margaret Hospital, Hong Kong
• Investigators: Study Director: Samuel Ka-Kin Ling, Assistant Professor (Clinical) of Orthopaedics & Traumatology

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2024
• Primary Completion (Estimated): April 20, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 5, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: CREC2023.572

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No