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NCT06160817 | COMPLETED | Diabetic Foot Ulcer

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

Complutense University of Madrid

Information provided by (Responsible Party):

FRANCISCO JAVIER ALVARO AFONSO

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

Condition or disease

Diabetic Foot Ulcer

Diabetic Foot

Wound Heal

Intervention/treatment

Conservative sharp debridement

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 16 participants
Masking : TRIPLE
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.
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-01-11
Estimated Primary Completion Date : 2024-04-30
Estimated Study Completion Date : 2024-05-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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).
Ulcer Location and Debridement Frequency: Weekly vs. Biweekly Sharp Debridement in Diabetic Foot Ulcers

Location Details

NCT06160817

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Locations

Not yet recruiting

Spain,

Podicology University Clinic, Complutense University

Madrid, Spain, 28040