Tests a hyaluronic acid cream to prevent foot ulcers in people with diabetes
Tests a hyaluronic acid cream against urea cream in adults with diabetes and nerve damage.
Plain-language title generated from the registry record
Registry title: 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.
Key facts
- Where
- Málaga, SpainSee the site
Where in Spain
- University of MalagaMálaga, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Malaga
- Trial code
- NCT07131410
- Record updated
- 20 August 2025
- Original description
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.Read full original descriptionShow less
Efficacy of Hyaluronic Acid Cream in Preventing Foot Ulceration Risk in Patients With Type 2 Diabetes and Moderate-to-Severe Peripheral Neuropathy
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.
Inclusion: 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: 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.