Effect of Ulcer Location on Debridement Frequency: A Pilot Randomized Controlled Trial Comparing Weekly and Second-weekly Sharp Debridement in Diabetic Foot Ulcers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Healing time
Study Overview
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:
- 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
This study employs a double-blind design. The treating clinician, responsible for administering the sharp debridement, is the sole individual aware of the patients' treatment group assignments. Both the participants and the key study personnel, including the principal investigator responsible for data collection and the data analyst responsible for data interpretation, are blinded to the treatment allocation. This approach aims to minimize potential biases and ensure a rigorous evaluation of the effects of weekly and biweekly sharp debridement on granulation tissue and healing time in patients with diabetic foot ulcers.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
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.
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
Secondary Outcomes
- Reduction in ulcer area(Weekly over a period of 12 weeks.)
- Clinical characteristics of the ulcer: Type of Tissue in the Wound Bed(Weekly over a period of 12 weeks.)
- Clinical characteristics of the ulcer : Perilesional Skin(Weekly over a period of 12 weeks.)
- Clinical characteristics of the ulcer: Perilesional Edges(Weekly over a period of 12 weeks.)
- Clinical characteristics of the ulcer: Exudate Level(Weekly over a period of 12 weeks.)
- Clinical characteristics of the ulcer: Local Clinical Signs of Infection(Weekly over a period of 12 weeks.)
Investigators
FRANCISCO JAVIER ALVARO AFONSO
Associate Professor with a Ph.D
Universidad Complutense de Madrid