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

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:

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

Study Overview

• Status: Completed
• Conditions: Diabetic Foot; Diabetic Foot Ulcer; Wound Heal
• Intervention / Treatment: Procedure: Conservative sharp debridement

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

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Clínica Universitaria Podología, Universidad Complutense

Participation Criteria

Eligibility Criteria

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

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.
Active Comparator: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 to 12 weeks
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	once per week until wound closure, with a maximum follow-up period of 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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	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)	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	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	Weekly over a period of 12 weeks.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SINBAD classification of diabetic foot ulcers	Application of the SINBAD (Site, Ischemia, Neuropathy, Bacterial Infection, Area, and Depth) classification system to categorize and characterize diabetic foot ulcers	Weekly over a period of 12 weeks.

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Principal Investigator: Francisco Javier Álvaro Afonso, Podiatrist, University Podiatry Clinic, "Universidad Complutense de Madrid"

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2024
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): May 6, 2024

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes; Diabetic foot ulcer; wound healing; Sharp wound debridement
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer
• Other Study ID Numbers: 23/695-EC_X

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