Comparative Diagnostic Evaluation of Non-Invasive Instrumental Methods for Assessing Plantar Hyperkeratosis in Healthy Subjects and Patients With Diabetes Mellitus Without Active Ulceration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Plantar Hyperkeratosis Surface Hardness (Shore A Scale)
研究概览
简要总结
This randomized clinical trial aims to compare the diagnostic performance, reproducibility, and agreement of several non-invasive instrumental methods for assessing plantar hyperkeratosis hardness in healthy subjects and patients with diabetes mellitus without active foot ulceration.
Participants will be evaluated in a single study session using plantar pressure platform analysis, durometer measurements, ultrasound elastography, and infrared thermography. The study seeks to identify the most reliable and discriminative methods for clinical and preventive assessment of plantar hyperkeratosis, particularly in populations at risk for diabetic foot complications.
详细描述
This is a randomized, controlled, cross-sectional clinical trial with two parallel groups: healthy subjects and patients with diabetes mellitus without active or recent plantar ulceration.
All participants present at least one clinically identifiable plantar hyperkeratosis. Each subject undergoes a standardized assessment in a single session using four non-invasive instrumental techniques: plantar pressure platform, durometer, ultrasound elastography, and infrared thermography.
The order of application of the instrumental methods is randomized. Primary outcomes include superficial hardness, tissue stiffness, plantar pressure distribution, and plantar surface temperature. Secondary outcomes include demographic, anthropometric, and clinical variables.
The study aims to compare inter-group differences, method agreement, reproducibility, and discriminative capacity of each instrumental technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistical analyst assessing study outcomes will be blinded to participant group allocation. Due to the nature of the instrumental assessments, participant and investigator blinding was not feasible.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Presence of at least one clinically identifiable plantar hyperkeratosis
- •Intact skin without ulceration
- •Ability to maintain standing position for at least 30 seconds
- •Signed informed consent
- •Additional Inclusion Criteria for Diabetes Mellitus Group:
- •Medical diagnosis of type 1 or type 2 diabetes mellitus
- •No active foot ulcer
- •No history of foot ulcer within the previous 12 months
排除标准
- •Active plantar ulcer, pre-ulcerative lesion, or recent ulcer scar
- •Severe peripheral neuropathy (absence of protective sensation with 10 g monofilament)
- •Severe peripheral arterial disease (Ankle-Brachial Index < 0.8)
- •Foot surgery within the previous 6 months
- •Active inflammatory, infectious, or dermatological condition at measurement site
- •Use of keratolytic treatments or debridement within the previous 15 days
- •Inability to complete the full assessment protocol
研究组 & 干预措施
Healthy Subjects With Plantar Hyperkeratosis
Participants without diabetes mellitus presenting plantar hyperkeratosis who will undergo a single-session standardized instrumental assessment including pressure platform analysis, durometer measurement, elastography, and infrared thermography.
干预措施: Instrumental Assessment of Plantar Hyperkeratosis (Diagnostic Test)
Diabetes Mellitus Without Active Foot Ulcer
Participants diagnosed with diabetes mellitus (type 1 or type 2) without active foot ulcer, presenting plantar hyperkeratosis, who will undergo the same single-session standardized instrumental assessment including pressure platform analysis, durometer measurement, elastography, and infrared thermography.
干预措施: Instrumental Assessment of Plantar Hyperkeratosis (Diagnostic Test)
结局指标
主要结局
Plantar Hyperkeratosis Surface Hardness (Shore A Scale)
时间窗: Baseline (day 0, single study visit)
Mean superficial hardness value measured using a calibrated Shore A durometer applied perpendicularly over the plantar hyperkeratosis. The average of three consecutive measurements will be analyzed.
次要结局
- Tissue Stiffness (Elastography)(Baseline (day 0, single study visit))
- Maximum and Mean Plantar Pressure at Hyperkeratosis Site(Baseline (day 0, single study visit))
- Surface Temperature of Plantar Hyperkeratosis (Infrared Thermography)(Baseline (day 0, single study visit))
研究者
Ángel Díaz del Río
Principal Investigator
University of Seville