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Evaluation of cannabidiol and urea 10%.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1. Complete formula. | Experimental | 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. | Experimental | Participants in this group received a cream with cannabidiol, urea 10% as active ingredients during 1 month. |
|
| Group 3. Base formula. | Placebo Comparator | Participants in this group received a base cream with no active ingredients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of neuropathic pain. | Neuropathic pain was assessed using the validated neuropathic pain assessment scale. | From randomisation and delivery of the assigned formula until the end of the intervention after one month of application. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin quality assessment | The assessment of skin quality was carried out using the validated questionnaire 'Injury Risk and Skin Quality Assessment Questionnaire'. | From randomisation and delivery of the assigned formula until the end of the intervention after one month of application. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Luis Lázaro Martinez, Podiatrist | ClÃnica Universitaria de podologÃa de la Universidad Complutense de Madrid | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facultad de EnfermerÃa, Fisioterapia y PodologÃa de la Universidad Complutense de Madrid | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31793418 | Background | Xu DH, Cullen BD, Tang M, Fang Y. The Effectiveness of Topical Cannabidiol Oil in Symptomatic Relief of Peripheral Neuropathy of the Lower Extremities. Curr Pharm Biotechnol. 2020;21(5):390-402. doi: 10.2174/1389201020666191202111534. |
| Label | URL |
|---|---|
| Research background on the effect of topical cannabidiol on various neuropathies. | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D017719 | Diabetic Foot |
| D003929 | Diabetic Neuropathies |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014508 | Urea |
| D005526 | Food, Formulated |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D019648 | Foods, Specialized |
| D005502 | Food |
| D000066888 |
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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.
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|
| 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. |
|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |