Ulcer Location and Debridement Frequency: Weekly vs. Biweekly Sharp Debridement in Diabetic Foot Ulcers

NCT ID: NCT06160817

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-11
• Study Completion Date: 2024-05-06

Brief 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. 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?

2. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Weekly 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.

Group Type: ACTIVE_COMPARATOR

Conservative sharp debridement

Intervention Type: PROCEDURE

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.

Biweekly 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.

Group Type: ACTIVE_COMPARATOR

Conservative sharp debridement

Intervention Type: PROCEDURE

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.

Interventions

Conservative sharp debridement

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.
• 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

Exclusion Criteria

• 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.
• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

FRANCISCO JAVIER ALVARO AFONSO

Associate Professor with a Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francisco Javier Álvaro Afonso, Podiatrist

Role: PRINCIPAL_INVESTIGATOR

University Podiatry Clinic, "Universidad Complutense de Madrid"

Locations

Clínica Universitaria Podología, Universidad Complutense

Madrid, , Spain

Countries

Spain

Other Identifiers

23/695-EC_X

Identifier Type: -

Identifier Source: org_study_id