Effectiveness of CBD for Neuropathic Pain in Diabetic Foot Neuropathy

Not Applicable

Completed

• Conditions: Neuropathic Pain Associated With Diabetic Peripheral Neuropathy; Xerosis Cutis
• Interventions: Drug: Group 1. Complete formula; Drug: Group 2. Cannabidiol and Urea 10% formula.; Drug: Group 3. Placebo formula.

• Registration Number: NCT07162454
• Lead Sponsor: Universidad Complutense de Madrid

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.

Study Timeline

• Study Start: 2024-11-01
• Primary Completion: 2025-05-31
• Study Completion: 2025-06-30
• Status Verified: 2025-09
• Study First Submitted: 2025-09-01
• Study First Submitted QC: 2025-09-01
• Last Update Submitted: 2025-09-01
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1. Complete formula.	Group 1. Complete formula	Participants in this group received a cream with cannabidiol, urea 10%, arnica and menthol as active ingredients during 1 month.
Group 2. Cannabidiol and Urea 10% formula.	Group 2. Cannabidiol and Urea 10% formula.	Participants in this group received a cream with cannabidiol, urea 10% as active ingredients during 1 month.
Group 3. Base formula.	Group 3. Placebo formula.	Participants in this group received a base cream with no active ingredients.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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'.

Trial Locations

Locations (1)

Facultad de Enfermería, Fisioterapia y Podología de la Universidad Complutense de Madrid; 🇪🇸 Madrid, Spain