Clinical trial NCT06160817: Ulcer Location and Debridement Frequency: Weekly vs. Biweekly Sharp Debridement in Diabetic Foot Ulcers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Diabetic Foot
Wound Heal
Keywords: Diabetes
Diabetic foot ulcer
Sharp wound debridement
wound healing
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

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


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).

Primary outcomes:
measure: Clinical presentation of the ulcer bed
timeFrame: once per week until wound closure, with a maximum follow-up period of 12 weeks
measure: Healing time
timeFrame: 1 to 12 weeks
Secondary outcomes:
measure: Reduction in ulcer area
timeFrame: Weekly over a period of 12 weeks.
measure: Clinical characteristics of the ulcer : Perilesional Skin
timeFrame: Weekly over a period of 12 weeks.
measure: Clinical characteristics of the ulcer: Perilesional Edges
timeFrame: Weekly over a period of 12 weeks.
measure: Clinical characteristics of the ulcer: Exudate Level
timeFrame: Weekly over a period of 12 weeks.
measure: Clinical characteristics of the ulcer: Type of Tissue in the Wound Bed
timeFrame: Weekly over a period of 12 weeks.
measure: Clinical characteristics of the ulcer: Local Clinical Signs of Infection
timeFrame: Weekly over a period of 12 weeks.
Other outcomes:
measure: SINBAD classification of diabetic foot ulcers
timeFrame: Weekly over a period of 12 weeks.
Locations:
city: Madrid
country: Spain
facility: Clínica Universitaria Podología, Universidad Complutense
Study officials:
affiliation: University Podiatry Clinic, "Universidad Complutense de Madrid"
name: Francisco Javier Álvaro Afonso, Podiatrist
role: PRINCIPAL_INVESTIGATOR
References: