Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, Xerosis Cutis
Conditions
Keywords
Diabetes mellitus, Diabetic foot, Diabetic neuropathy, Neuropathic pain, Cannabidiol, Urea 10%
Brief summary
Evaluation of cannabidiol and urea 10%.
Detailed description
This study evaluated the impact of cannabidiol on neuropathic pain and the action of urea 10% on skin quality in patients with diabetic foot syndrome and diabetic neuropathy.
Interventions
DRUGGroup 1. Complete formula
After fulfilling the criteria and agreeing to participate in the study, patients who were included in group 1 after randomisation were evaluated and received a topical cream with cannabidiol, Urea 10%, arnica and menthol as active ingredients. After one month of application of the formula, a second evaluation was carried out.
DRUGGroup 2. Cannabidiol and Urea 10% formula.
After meeting the criteria and agreeing to participate in the study, the patients who were included in group 2 after randomisation were evaluated and received a topical cream containing cannabidiol and 10% urea. After one month of application of the formula, a second evaluation was carried out.
DRUGGroup 3. Placebo formula.
Participants included in this group after randomisation received a formulation with no active ingredients included in its composition and were assessed at baseline and after one month.
Sponsors
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Three groups were created and each group was assigned a different composition. A baseline and a final evaluation was performed after one month to assess the neuropathic pain and skin quality of the participants.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients all biological sexes * Patients of legal age (18 years). * Patients without cognitive impairment * Patients Diagnosed with diabetic neuropathy, * Patients who were able to complete the neuropathic pain scale autonomously, cooperatively and independently.
Exclusion criteria
* Patients who declined participation * Patients with critical ischaemia and * Patients with a history of allergy or hypersensitivity to any of the components of the cream were excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of neuropathic pain. | From randomisation and delivery of the assigned formula until the end of the intervention after one month of application. | Neuropathic pain was assessed using the validated neuropathic pain assessment scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin quality assessment | From randomisation and delivery of the assigned formula until the end of the intervention after one month of application. | The assessment of skin quality was carried out using the validated questionnaire 'Injury Risk and Skin Quality Assessment Questionnaire'. |
Countries
Spain
Outcome results
None listed