Diabetic Foot
Conditions
Interventions
This is a randomized, comparative, case-control, double-blind clinical trial. Control group: 52 people with diabetic foot ulcers will receive conventional treatment with antimicrobial gauze and hydrog
Intervention group 3: 52 people with diabetic foot ulcers will receive treatment with NEOVSR2024, a healing nanoemulsion based on the standardized volatile oil of Salvia rosmarinus 5%. Intervention gr
Sponsors
Hospital Universitário da Universidade Federal do Amapá
Universidade Federal do Amapá
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adult males or females. = 18 years of age. Signed written informed consent. Diagnosis of type 1 or 2 diabetes mellitus. HbA1c = 86 mmol/mol (= 10%) at screening. Subjects with at least first time with a full-thickness ulcer or recurrent ulcer (below the ankle) that fulfills all of the following criteria at screening and at the start of the protocol: A non-Interdigital wound. Accessible for administration of the products, tests, evaluations, and wound study procedures. Persistence of the wound for at least 6 weeks prior to the start of the protocol. Complete minimal skin ulcer without detachment, without muscle, tendon, or bone exposure. A wound area of 1.0 - 5.0 cm2 after cutting or mechanical debridement at screening. During the 2 weeks between the start of the initial phase and baseline, the wound size should not decrease by more than 30% or increase by more than 25%, which corresponds to wound areas of 0.7 - 6.3 cm2. Pressure on the tip of the foot =30 mm Hg. Diabetic patients who present neuropathic and/or ischemic ulcers without infection at any stage of healing. Willing to refrain from using unapproved lotions or creams on the site of injury and the surrounding area during the treatment period. Willing to refrain from washing the treated area for at least 8 hours after application of study medication. Laboratory values for the tests listed below within protocol-defined reference ranges, or "out of range" test results that are clinically acceptable for study participation. Ability to follow study instructions and likely complete all study requirements. Agree to participate in the research by signing the Informed Consent Form
Exclusion criteria
Exclusion criteria: Be under 18 years old. Pregnant or breastfeeding. Patients who do not fit into the ulcer classification stipulated for the study (severe injuries with deep infection, or with indication for amputation). Patients with cognition problems that make it difficult to apply treatment. Concomitant disease or treatment that suppresses the immune system. Chronic medical condition that, without the judgment of the investigator(s), would disrupt study performance or place the patient at undue risk. Known sensitivity to any of the components of the study medication. Treatment with systemic chemotherapy agents in the 6 months prior to selection. Use of systemic retinoids in the 6 months prior to the screening period. the leg presenting the planned or performed wound within 8 weeks prior to screening. Has any disease conditions, including ulcerative dermatologic disorders and vasculitis, or comorbidities that may preclude the subject from participating in the study or confound assessment of the safety profile and effect on wound healing. Female subjects of childbearing potential unless using a contraceptive method with a failure rate < 1% to prevent pregnancy. Patients who do not have continuous monitoring by their family or caregiver and those who cannot attend within the specified period for evaluation and dressing changes (lost to follow-up)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find an improvement in the healing of ulcers in the foot of patients with diabetes with the use of nanotechnological products based on medicinal plants, as a comparison of conventional treatments. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that there will be no difference in the healing time of ulcers on the foot of patients with diabetes with the use of nanotechnological products based on medicinal plants, as a comparison of conventional treatments. | — |
Countries
Brazil
Contacts
Public ContactSamya Dias
Universidade Federal do Amapá
Outcome results
None listed