Evaluation of Materials for the Distribution of Pressure in the Treatment of Neuroischemic Ulcers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: felt padding.
- Who it may be relevant to
- Registry conditions: Diabetic Complications, Foot Care. Basic parameters: 55 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The hypothesis of this study is based on the premise that pressure-distributing materials with superior biomechanical and tissue response properties will be capable of improving the healing rate of neuropathic ulcers. The overarching objective of the present project is to assess the influence of the nature and method of application of the materials under study on tissue response, the reduction of pressure on the sole of the foot, and the healing of neuropathic ulcers in patients with diabetes mellitus.
Detailed description
The study is divided into two distinct phases:
The following analysis is concerned with the characteristics of materials that are employed for the purpose of the distribution of pressure. This will entail the meticulous analysis of the response exhibited by the materials, with the objective of ascertaining their true biomechanical behaviour in volunteers devoid of active ulcers.
The materials selected in the first part will be applied for the treatment of revascularised neuroischaemic ulcers. This will determine which of the materials is the most suitable for treating the lesion.
Interventions
- Other felt padding
The 5 mm felt pad is applied for 4 days and then removed. After allowing the skin at least 48 hours to recover, the 10 mm felt pad is applied, also for 4 days.
Primary outcome measures
- Near-infrared perfusion index (NIR perfusion) [Time frame: Baseline and 4 days]
Secondary outcome measures (7)
- Thermography [Time frame: Baseline and 4 days]
- Peak pressure (Pmax) [Time frame: Baseline and 4 days]
- Tissue oxygen saturation (StO₂) [Time frame: Baseline and 4 days]
- Tissue hemoglobin index (THI) [Time frame: Baseline and 4 days]
- Tissue wáter index (TWI) [Time frame: Baseline and 4 days]
- Tissue lipid index (TLI) [Time frame: Baseline and 4 days]
- Mean pressure (Pmean) [Time frame: Baseline and 4 days]
Eligibility criteria
Inclusion criteria
- Aged between 55 and 75.
- Diagnosis of diabetes mellitus.
- Patients with an ankle-brachial index of >0.8 and <1.2.
- Signature of the informed consent form
Exclusion criteria
- Leg or foot injuries or ulcers that cause pain and prevent normal movement in both lower limbs.
- Foot trauma within the last month.
- Inability to adhere to the full schedule of measurements required by the study.
- Participants who do not sign the informed consent form.
- Known contact dermatitis to any of the study materials
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Spain · 1 center
- Hospital Universitario y Politécnico La Fe — Valencia
Identifiers
NCT: NCT07620379 · 2020-672-1