Diabetic Foot Ulcer, Wound Healing
Conditions
Interventions
This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial involving 60 adult participants diagnosed with type 2 diabetes mellitus and presenting with neuropathic or ischemi
Sponsors
Sociedade De Educação Superior e Cultura Brasil S.A.
Associação Brasileira de Cannabis Medicinal (Santa Cannabis)
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age 18 years or older. diagnosis of type 2 diabetes mellitus. presence of neuropathic or ischemic wound in lower limbs. under follow-up at primary health units or at Policlínica Santa Maria in the city of Cajazeiras. medical prescription for use of the Cannabis-based cream. signing of the informed consent form
Exclusion criteria
Exclusion criteria: Wounds not related to diabetes such as those of traumatic or burn origin. known allergy to any component of the cream formulation. simultaneous participation in another clinical trial. presence of severe clinical or psychiatric conditions that impair protocol adherence. pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the complete wound healing rate in patients with type 2 diabetes mellitus and neuropathic or ischemic ulcers treated with a topical cream containing broad-spectrum Cannabis sativa L. extract with cannabidiol compared to placebo after 60 days of twice-daily application. Complete healing will be defined as total epithelialization of the wound with skin closure and absence of exudate and will be assessed weekly using a validated clinical scale and standardized photographic documentation | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage reduction in wound area in square centimeters assessed weekly over 60 days. mean time to partial and complete epithelialization of the wound in days. local pain intensity assessed weekly using a visual analog scale. presence of local signs of infection such as edema erythema and purulent exudate recorded at each clinical visit. occurrence of adverse effects related to the use of the cream such as itching burning or contact dermatitis monitored throughout the study. patient satisfaction with the treatment evaluated by a structured questionnaire at the end of the study | — |
Countries
Brazil
Contacts
Public ContactRafael Bitencourt
Universidade do Sul de Santa Catarina (UNISUL)
Outcome results
None listed