Diabetic NeuropathiesNCT06357884
Short-term Effect of Podiatric Callus Debridement on Plantar Pressure in Diabetic Neuropathic Patients
A study testing Callus debridement in people with Diabetic Neuropathies and Plantar Callus, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathies, Plantar Callus
- What is being tested?
- Callus debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Feb 2024to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- Presence of plantar callus
- Compliance with instructions (in Chinese or english)
- Ability to read and write (in Chinese or english)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Callus debridement
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Callus debridementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Callus debridement | Experimental | Callus debridement which aligns with routine clinical practice of the Princess Margaret Hospital Podiatry Department. Receives: Procedure: Callus debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plantar pressure (PPP) (unit: kPa)
The maximum or highest pressure within foot
Measured: Before treatment, immediately after treatment and 3-4 weeks post-treatment
Secondary outcomes (4)
Pressure time integral (PTI) (unit: kPa*sec)
The amount of pressure relative to the time that the pressure is present
Measured: 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
Measured: 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
Measured: 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)
Measured: Before treatment, 1 week after treatment and 3-4 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start23 Feb 2024
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Hong Kong
- Responsible party
- Principal investigator, Joanne Tze Yan LAI, Chinese University of Hong Kong
- Investigators
- Samuel Ka-Kin Ling, Study director, Assistant Professor (Clinical) of Orthopaedics & Traumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357884
- Sponsor's protocol ID
- CREC2023.572
- Status last verified
- Jul 2024
- First submitted
- 5 Apr 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effect of Podiatric Callus Debridement on Plantar Pressure in Diabetic Neuropathic Patients
- ClinicalTrials.gov ID
- NCT06357884
- Acronym / sponsor ID
- CREC2023.572
- Conditions
- Diabetic Neuropathies, Plantar Callus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Hong Kong
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Callus debridement | Experimental | Procedure: Callus debridementCallus debridement which aligns with routine clinical practice of the Princess Margaret Hospital Podiatry Department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- Peripheral vascular disease
- Painful neuropathy
- Charcot deformity
- Undergone any form of callus debridement in the past 6 weeks
- Active foot ulcer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Callus debridementEligible 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. | Procedure or surgery | Callus debridement |
Primary outcome
Peak plantar pressure (PPP) (unit: kPa)
Time frame: Before treatment, immediately after treatment and 3-4 weeks post-treatment
The maximum or highest pressure within foot
4 secondary outcomes
Pressure time integral (PTI) (unit: kPa*sec)
Time frame: Before treatment, immediately after treatment and 3-4 weeks post-treatment
Peak pressure gradient (PPG) (unit: kPa/cm)
Time frame: Before treatment, immediately after treatment and 3-4 weeks post-treatment
Forefoot to rearfoot peak pressure ratio (F/R ratio)
Time frame: Before treatment, immediately after treatment and 3-4 weeks post-treatment
Foot and Ankle Outcome Score (FAOS)
Time frame: Before treatment, 1 week after treatment and 3-4 weeks post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Ka-Kin Ling study director
Assistant Professor (Clinical) of Orthopaedics & Traumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Callus debridement in people with Diabetic Neuropathies and Plantar Callus, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak plantar pressure (PPP) (unit: kPa) (time frame: Before treatment, immediately after treatment and 3-4 weeks post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.