Efficacy of Hyaluronic Acid Cream in Preventing Foot Ulceration Risk in Patients With Type 2 Diabetes and Moderate-to-Severe Peripheral Neuropathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of Malaga
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- Photo analysis
Study Overview
Brief Summary
A triple-blind randomized clinical trial aimed at evaluating the efficacy of a hyaluronic acid cream in preventing foot ulcers in patients with type 2 diabetes and moderate-to-severe peripheral neuropathy.
The primary objective is to determine the effectiveness of this cream in preventing ulcerations after 12 months of use in this population, compared to the use of another cream containing 10% urea. Secondary objectives include assessing changes in hydration, skin stiffness, and pH across various areas of the foot, with results compared between the intervention and control groups.
The study will be conducted at Miguel Hernández University between 2025 and 2027. A total of 166 adult participants with type 2 diabetes and moderate-to-severe peripheral neuropathy will be randomized into two groups: the intervention group, which will apply the hyaluronic acid cream daily, and the control group, which will use a 10% urea cream. Measurements of skin hydration, pH, and stiffness, along with the xerosis index, will be taken during three scheduled visits (at 3, 6, and 12 months). Neuropathy will be assessed through sensitivity and reflex tests, while sociodemographic and clinical variables will be recorded at the start of the study.
Participants will log their treatment adherence and any potential adverse effects through a mobile application. The data obtained on skin hydration, pH, and stiffness will be analyzed to identify differences between the two groups, with differences considered statistically significant if p < 0.05.
This study aims to provide evidence on the effectiveness of hyaluronic acid in preventing ulcerations and improving skin characteristics of the foot in patients with diabetes and peripheral neuropathy.
Detailed Description
Hypothesis
The hypothesis is that the daily application of a cream with hyaluronic acid on the foot does not reduce the incidence of foot ulcers in patients with type 2 diabetes and moderate-to-severe peripheral neuropathy after one year of follow-up, compared to the application of a cream with 10% urea.
Primary Objective
Evaluate the efficacy of topical hyaluronic acid cream over 12 months in preventing foot ulceration in patients with moderate-to-severe peripheral neuropathy, compared to the application of a cream with 10% urea.
Secondary Objectives
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults aged 18 or older, diagnosed with type 2 diabetes and moderate-to-severe peripheral neuropathy (diagnosed with a score ≥6 on the Michigan scale), who have not used any topical moisturizer or keratolytic agents on their feet for at least two weeks prior
Exclusion Criteria
- •Presence of ulcerative skin lesions on the foot Diagnosed peripheral arterial disease, indicated by the absence of both peripheral pulses and/or Ankle-Brachial Index less than 1 or greater than 1.4 Dermatological diseases affecting foot hydration: atopic dermatitis, ichthyosis, or psoriasis Use of custom-made plantar orthoses, as the material could affect foot hydration
Arms & Interventions
Patients who apply 10% urea daily
Participants will apply a 10% urea cream following the same protocol. Patients will receive the container cream for application on both feet after thoroughly washing and drying them. It is recommended to use an amount the size of a hazelnut for each foot, spreading it in a thin layer over the entire foot, excluding the interdigital area. The application will be done every night for twelve months. The product will be massaged into the foot for 15 seconds. During the study, participants will not be allowed to use any other topical product (cream, emulsion, gel, lotion, or oil) on their feet and/or nails.
Intervention: Group hialuronyc (Other)
Patients who apply hyaluronic acid daily
Patients will receive the container with Hialucic® cream for application on both feet after thoroughly washing and drying them. It is recommended to use an amount the size of a hazelnut for each foot, spreading it in a thin layer over the entire foot, excluding the interdigital area. The application will be done every night for twelve months. The product will be massaged into the foot for 15 seconds. During the study, participants will not be allowed to use any other topical product (cream, emulsion, gel, lotion, or oil) on their feet and/or nails.
Intervention: Group hialuronyc (Other)
Outcomes
Primary Outcomes
Photo analysis
Time Frame: 12 months
The occurrence of dermal lesions on the skin will be recorded, specifying their location, type, and size. The patient will be able to report any dermal lesion to the investigator via the app, and the lesion will be assessed at the university clinic, regardless of the study's scheduled follow-up visit
Secondary Outcomes
No secondary outcomes reported
Investigators
Gabriel Gijon-Nogueron
Efficacy of Hyaluronic Acid Cream in Preventing Foot Ulceration Risk in Patients with Type 2 Diabetes and Moderate-to-Severe Peripheral Neuropathy: A Randomized Clinical Trial.
University of Malaga