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Completed

NCT Number: NCT07162454

Effectiveness of CBD for Neuropathic Pain in Diabetic Foot Neuropathy

Evaluation of cannabidiol and urea 10%.

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Key information

Conditions

Xerosis Cutis Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Associated With Diabetic Peripheral Neuropathy Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Enfermería, Fisioterapia y Podología de la Universidad Complutense de Madrid

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group 1. Complete formula

Drug

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.

Group 2. Cannabidiol and Urea 10% formula.

Drug

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.

Group 3. Placebo formula.

Drug

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.

Primary outcomes

  1. Assessment of neuropathic pain.

    Time frame: 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 outcomes

  1. Skin quality assessment

    Time frame: 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'.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Official study title

A Triple-Blind Randomised Clinical Trial on the Effectiveness of CBD for Neuropathic Pain in Diabetic Foot Neuropathy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 9, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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