Diabetic Foot UlcerNCT06160817
Ulcer Location and Debridement Frequency: Weekly vs. Biweekly Sharp Debridement in Diabetic Foot Ulcers
A study testing Conservative sharp debridement in people with Diabetic Foot Ulcer and Diabetic Foot, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The goal of this clinical trial is to determine the optimal frequency for sharp debridement in promoting the healing of diabetic foot ulcers (DFUs). The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer, Diabetic Foot, Wound Heal
- What is being tested?
- Conservative sharp 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 siteSpain
- Study dates
- 11 Jan 2024to 6 May 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
- Men and women aged 18 years or older who provide written informed consent.
- Patients with Type 1 or Type 2 Diabetes mellitus with a glycated hemoglobin (HbA1c) concentration ≤ 10% (determined in the past 3 months).
- DFUs with the following locations: digital, under metatarsal head, midfoot, and hindfoot.
- DFUs of grades IA, IIA, IB, IIB, IC, IIC, ID, and IID according to the University of Texas Classification.
- DFUs with grades PEDIS 1 - no infection, PEDIS 2 - mild infection, and PEDIS 3 - moderate infection, as per the PEDIS-IDSA classification.
- Neuropathic and neuroischemic ulcers.
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- DFUs with grades 0 (absence of ischemia), 1 (mild ischemia), and 2 (moderate ischemia) according to the WIfI (Wound, Ischemia, and foot Infection) Classification, determined by palpation of at least one distal pulse, Ankle-brachial index (ABI) ≥ 0.5, ankle systolic blood pressure ≥ 50 mmHg, or a value ≥ 30 mmHg for toe systolic blood pressure and transcutaneous oxygen pressure (TcpO2).
- Study ulcer surface area between 0.5 cm² and 30 cm² after debridement.
- Duration of the DFU between 2-50 weeks
Who cannot join
- Patients with severe renal insufficiency requiring dialysis.
- Patients with congestive heart failure (CHF) above Class II, meaning CHF that causes a limitation of physical activity.
- Patients with active coronary disease or a significant adverse cardiac event in the past 18 months, defined as any of the following circumstances: fluctuating symptoms attributed to coronary disease, interventional procedure such as coronary artery bypass grafting or percutaneous coronary intervention (stent placement), worsening of cardiac ejection fraction, increased need for medication used to treat coronary disease, or known presence of coronary lesion with ≥ 70% diameter stenosis that has been previously revascularized.
- Patients with a life expectancy < 6 months.
- Patients with Acquired Immunodeficiency Syndrome (AIDS) or confirmed Human Immunodeficiency Virus (HIV) infection.
- Patients with confirmed diagnosis of hepatitis C virus antibodies or hepatitis C virus surface antigen.
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- Pregnant or lactating women, or women of childbearing age not following an effective contraceptive method.
- Patients with critical limb ischemia determined by: Absence of both distal pulses or an ABI ≤ 0.4, ankle systolic blood pressure < 50 mmHg, or a value < 30 mmHg for toe systolic blood pressure and TcpO2, translating to Grade 3 (severe ischemia) according to the WiFi classification.
- DFUs of grades IIIA, IIIB, IIIC, and IIID according to the University of Texas Classification.
- DFUs with PEDIS grades 3O - Moderate infection with osteomyelitis, PEDIS 4 - Severe infection (excluding PEDIS 4O) according to the PEDIS-IDSA classification.
- Patients unable to understand the purposes and objectives of the study.
- Patients with a history of non-compliance with medical treatments (assessed through patient medical history, poor adherence to previous treatments, and therapeutic non-compliance).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Clínica Universitaria Podología, Universidad Complutense
Madrid, 28040
About this study
Official title: Effect of Ulcer Location on Debridement Frequency: A Pilot Randomized Controlled Trial Comparing Weekly and Second-weekly Sharp Debridement in Diabetic Foot Ulcers
The goal of this clinical trial is to determine the optimal frequency for sharp debridement in promoting the healing of diabetic foot ulcers (DFUs).
The main questions it aims to answer are:
Read more
- What is the comparative effect of weekly sharp debridement versus biweekly sharp debridement in combination with conventional treatment on granulation tissue and healing time in patients with DFUs?
- What is the optimal modality or frequency of debridement based on the location of the DFU?
Participants (ulcerated diabetic patients) will:
- Undergo sharp debridement on a weekly basis (Group A).
- Undergo sharp debridement on a biweekly basis (Group B).
Researchers will compare Group A (weekly sharp debridement) with Group B (biweekly sharp debridement ) to see if the frequency of sharp debridement has a significant effect on granulation tissue and healing time in diabetic foot ulcers.
In each group, there will be patients with ulcers in different locations (toes, metatarsal heads, and midfoot/hindfoot) to assess the effect of debridement based on the lesion location
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot, Wound Heal
- Being tested
- Conservative sharp debridement
- Keywords
- Diabetes, Diabetic foot ulcer, Sharp wound debridement, wound healing
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative sharp debridementProcedure or surgery
The debridement method for all patients, regardless of the assigned sequence, will involve the removal of non-viable tissue from the ulcer bed, edges, and perilesional skin using a scalpel (No. 3) with a No. 10 and/or No. 15 blade, along with Adson forceps and straight dissecting forceps.
| Study group | Role | What they receive |
|---|---|---|
| Weekly Sharp Debridement | Active comparator | * Participants in this arm will undergo sharp debridement on a weekly basis.
* Purpose: Evaluate the effect of weekly sharp debridement, in combination with conventional treatment, on granulation tissue and healing time in diabetic foot ulcers. And assess if this regimen yields better outcomes for ulcers with a specific location.
* Active Comparator: Yes, as it represents an active treatment modality. Receives: Procedure: Conservative sharp debridement |
| Biweekly Sharp Debridement | Active comparator | * Participants in this arm will undergo sharp debridement on a biweekly basis.
* Purpose: Assess the impact of biweekly sharp debridement, in combination with conventional treatment, on granulation tissue and healing time in diabetic foot ulcers. And assess if this regimen yields better outcomes for ulcers with a specific location.
* Active Comparator: Yes, as it represents an active treatment modality. Receives: Procedure: Conservative sharp debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical presentation of the ulcer bed
The clinical presentation of the ulcer bed will be assessed using the Wollina Wound Score, a validated scale designed to comprehensively evaluate various aspects of wound healing.
The higher the score on this scale, the higher the quality of the wound granulation tissue. The maximum score is 7 points, and the minimum is 0.
The scale evaluates 3 items to which you assign a score as follows:
- Presence of granulation tissue in the wound bed: Absence = 0, one-quarter of the ulcer area = 1, half of the area = 2, three-quarters of the area = 3, and complete = 4.
- Tissue color: Pale = 0, pink = 1, and bright red = 2.
- Tissue consistency: Spongy = 0, and solid = 1
Measured: once per week until wound closure, with a maximum follow-up period of 12 weeks
Healing time
Healing time will be measured (in weeks) as the duration from the initiation of the study intervention until complete closure of the diabetic foot ulcer.
Measured: 1 to 12 weeks
Secondary outcomes (6)
Reduction in ulcer area
Change in ulcer area at each follow-up visit compared to the initial measurement. The reduction in ulcer area will be quantified in square centimeters.
Measured: Weekly over a period of 12 weeks.
Clinical characteristics of the ulcer : Perilesional Skin
Assessment of the skin surrounding the ulcer.
- Intact Skin
- Erythematous skin
- Edematous skin
- Macerated skin
- Scaly or dry skin
- Necrotic skin
- Ecchymotic skin
- Hyperkeratotic skin
Measured: Weekly over a period of 12 weeks.
Clinical characteristics of the ulcer: Perilesional Edges
Examination of the edges surrounding the ulcer.
- Healthy edges
- Dry edges
- Necrotic edges
- Hyperkeratotic edges
- Macerated edges
- Hyperemic edges
- Erythematous edges
- Raised edges
- Detached edges
Measured: Weekly over a period of 12 weeks.
Clinical characteristics of the ulcer: Exudate Level
- Qualitative measurement: Absent, low, moderate or high
- Characterization of the wound exudate: serous, sanguineous, purulent, fibrinous and mixed (seropurulent, serosanguineous)
Measured: Weekly over a period of 12 weeks.
Clinical characteristics of the ulcer: Type of Tissue in the Wound Bed
Identification and categorization of the tissue present in the wound bed.
- Granulation
- Hypergranulation
- Slough
- Necrotic
Measured: Weekly over a period of 12 weeks.
Clinical characteristics of the ulcer: Local Clinical Signs of Infection
Systematic evaluation of any local clinical signs indicating infection.
- Presence
- Absence
Measured: Weekly over a period of 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start11 Jan 2024
- Primary completion30 Apr 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a prospective, randomized controlled trial design with parallel assignment. The primary objective is to assess the impact of two different debridement modalities, specifically weekly and biweekly sharp debridement, on granulation tissue and healing time in patients with diabetic foot ulcers (DFUs). The study includes three stratified groups based on the location of the ulcer: digital DFUs, DFUs under metatarsal heads, and DFUs in the plantar region of midfoot/heel. Participants meeting inclusion criteria will be randomly assigned to either the weekly or biweekly sharp debridement groups within each location-based stratum. The study aims to elucidate the optimal frequency of debridement based on ulcer location. Outcome measures include the assessment of granulation tissue and healing time. The trial is conducted at the University Podiatry Clinic, and the anticipated duration is from january to april 2024
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FRANCISCO JAVIER ALVARO AFONSO, Universidad Complutense de Madrid
- Investigators
- Francisco Javier Álvaro Afonso, Podiatrist, Principal investigator, University Podiatry Clinic, "Universidad Complutense de Madrid"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160817
- Sponsor's protocol ID
- 23/695-EC_X
- Status last verified
- May 2024
- First submitted
- 29 Nov 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ulcer Location on Debridement Frequency: A Pilot Randomized Controlled Trial Comparing Weekly and Second-weekly Sharp Debridement in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT06160817
- Acronym / sponsor ID
- 23/695-EC_X
- Conditions
- Diabetic Foot Ulcer, Diabetic Foot, Wound Heal
- Keywords
- Diabetes, Diabetic foot ulcer, Sharp wound debridement, wound healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 7 Dec 2023 (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.
The goal of this clinical trial is to determine the optimal frequency for sharp debridement in promoting the healing of diabetic foot ulcers (DFUs).
The main questions it aims to answer are:
- What is the comparative effect of weekly sharp debridement versus biweekly sharp debridement in combination with conventional treatment on granulation tissue and healing time in patients with DFUs?
- What is the optimal modality or frequency of debridement based on the location of the DFU?
Participants (ulcerated diabetic patients) will:
- Undergo sharp debridement on a weekly basis (Group A).
- Undergo sharp debridement on a biweekly basis (Group B).
Researchers will compare Group A (weekly sharp debridement) with Group B (biweekly sharp debridement ) to see if the frequency of sharp debridement has a significant effect on granulation tissue and healing time in diabetic foot ulcers.
In each group, there will be patients with ulcers in different locations (toes, metatarsal heads, and midfoot/hindfoot) to assess the effect of debridement based on the lesion location
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study employs a prospective, randomized controlled trial design with parallel assignment. The primary objective is to assess the impact of two different debridement modalities, specifically weekly and biweekly sharp debridement, on granulation tissue and healing time in patients with diabetic foot ulcers (DFUs). The study includes three stratified groups based on the location of the ulcer: digital DFUs, DFUs under metatarsal heads, and DFUs in the plantar region of midfoot/heel. Participants meeting inclusion criteria will be randomly assigned to either the weekly or biweekly sharp debridement groups within each location-based stratum. The study aims to elucidate the optimal frequency of debridement based on ulcer location. Outcome measures include the assessment of granulation tissue and healing time. The trial is conducted at the University Podiatry Clinic, and the anticipated duration is from january to april 2024
| Arm | Type | Receives |
|---|---|---|
| Weekly Sharp Debridement | Active comparator | Procedure: Conservative sharp debridement* Participants in this arm will undergo sharp debridement on a weekly basis. * Purpose: Evaluate the effect of weekly sharp debridement, in combination with conventional treatment, on granulation tissue and healing time in diabetic foot ulcers. And assess if this regimen yields better outcomes for ulcers with a specific location. * Active Comparator: Yes, as it represents an active treatment modality. |
| Biweekly Sharp Debridement | Active comparator | Procedure: Conservative sharp debridement* Participants in this arm will undergo sharp debridement on a biweekly basis. * Purpose: Assess the impact of biweekly sharp debridement, in combination with conventional treatment, on granulation tissue and healing time in diabetic foot ulcers. And assess if this regimen yields better outcomes for ulcers with a specific location. * Active Comparator: Yes, as it represents an active treatment modality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women aged 18 years or older who provide written informed consent.
- Patients with Type 1 or Type 2 Diabetes mellitus with a glycated hemoglobin (HbA1c) concentration ≤ 10% (determined in the past 3 months).
- DFUs with the following locations: digital, under metatarsal head, midfoot, and hindfoot.
- DFUs of grades IA, IIA, IB, IIB, IC, IIC, ID, and IID according to the University of Texas Classification.
- DFUs with grades PEDIS 1 - no infection, PEDIS 2 - mild infection, and PEDIS 3 - moderate infection, as per the PEDIS-IDSA classification.
Key exclusion criteria (12 listed)
- Patients with severe renal insufficiency requiring dialysis.
- Patients with congestive heart failure (CHF) above Class II, meaning CHF that causes a limitation of physical activity.
- Patients with active coronary disease or a significant adverse cardiac event in the past 18 months, defined as any of the following circumstances: fluctuating symptoms attributed to coronary disease, interventional procedure such as coronary artery bypass grafting or percutaneous coronary intervention (stent placement), worsening of cardiac ejection fraction, increased need for medication used to treat coronary disease, or known presence of coronary lesion with ≥ 70% diameter stenosis that has been previously revascularized.
- Patients with a life expectancy < 6 months.
- Patients with Acquired Immunodeficiency Syndrome (AIDS) or confirmed Human Immunodeficiency Virus (HIV) infection.
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 |
|---|---|---|
| Conservative sharp debridementThe debridement method for all patients, regardless of the assigned sequence, will involve the removal of non-viable tissue from the ulcer bed, edges, and perilesional skin using a scalpel (No. 3) with a No. 10 and/or No. 15 blade, along with Adson forceps and straight dissecting forceps. | Procedure or surgery | Biweekly Sharp Debridement, Weekly Sharp Debridement |
Primary outcome
Clinical presentation of the ulcer bed
Time frame: once per week until wound closure, with a maximum follow-up period of 12 weeks
The clinical presentation of the ulcer bed will be assessed using the Wollina Wound Score, a validated scale designed to comprehensively evaluate various aspects of wound healing. The higher the score on this scale, the higher the quality of the wound granulation tissue. The maximum score is 7 points, and the minimum is 0. The scale evaluates 3 items to which you assign a score as follows: * Presence of granulation tissue in the wound bed: Absence = 0, one-quarter of the ulcer area = 1, half of the area = 2, three-quarters of the area = 3, and complete = 4. * Tissue color: Pale = 0, pink = 1, and bright red = 2. * Tissue consistency: Spongy = 0, and solid = 1
Healing time
Time frame: 1 to 12 weeks
Healing time will be measured (in weeks) as the duration from the initiation of the study intervention until complete closure of the diabetic foot ulcer.
6 secondary outcomes
Reduction in ulcer area
Time frame: Weekly over a period of 12 weeks.
Clinical characteristics of the ulcer : Perilesional Skin
Time frame: Weekly over a period of 12 weeks.
Clinical characteristics of the ulcer: Perilesional Edges
Time frame: Weekly over a period of 12 weeks.
Clinical characteristics of the ulcer: Exudate Level
Time frame: Weekly over a period of 12 weeks.
Clinical characteristics of the ulcer: Type of Tissue in the Wound Bed
Time frame: Weekly over a period of 12 weeks.
Clinical characteristics of the ulcer: Local Clinical Signs of Infection
Time frame: Weekly over a period of 12 weeks.
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 8 May 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.
Francisco Javier Álvaro Afonso, Podiatrist principal investigator
University Podiatry Clinic, "Universidad Complutense de Madrid"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative sharp debridement in people with Diabetic Foot Ulcer and Diabetic Foot, run by Universidad Complutense de Madrid at 1 site in Spain.
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 12 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 8 May 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 Spain. 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?
Clinical presentation of the ulcer bed (time frame: once per week until wound closure, with a maximum follow-up period of 12 weeks). The study lists 2 primary outcomes in all. 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 8 May 2024.