diabetic foot
Conditions
Interventions
This will be a prospective, experimental, randomized, comparative, case-control study conducted at the Diabetic Foot Unit of the Primary Health Care Unit of the Federal University of Amapá and at the
group allocation. Volunteers aged over eighteen years, of both sexes, with a clinical diagnosis of diabetic foot and followed at the Diabetic Foot Unit of the Primary Health Care Unit of the Federal U
lesions will be grouped and classified according to type and risk category (risk 1, risk 2, or risk 3), based on predominant clinical findings, according to the definition of the International Diabete
Sponsors
Centro de Pesquisa Clínica do Hospital Universitário da Universidade Federal do Amapá
Universidade Federal do Amapá
Hospital Universitário Federal do Amapá
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adults aged 18 years and older; diagnosed with Type 1 or Type 2 Diabetes Mellitus; HbA1c = 86 mmol/mol (10%) at screening; presence of a full-thickness ulcer below the ankle, with a duration of 6 weeks or more, and measuring between 1.0 and 5.0 cm² after debridement, without exposure of muscle, tendon, or bone; toe pressure = 30 mmHg. Neuropathic and/or ischemic non-infected ulcer, at any stage of healing; change in ulcer area between screening and baseline within -30% to +25%; commitment to required care and no use of unauthorized products; ability to comply with the study protocol and to sign the informed consent form, including authorization for photographs
Exclusion criteria
Exclusion criteria: Pregnant or breastfeeding women; presence of an infected or highly exudative ulcer; indication for amputation; cognitive impairment; recent or current use of immunosuppressants, chemotherapy, or retinoids; unstable chronic diseases; hypersensitivity to components of the product; alcohol or drug abuse. Active Charcot deformity; inability or refusal to follow the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the proportion of participants with complete healing of the plantar ulcer at the end of the 14-week treatment period. This outcome will be verified through clinical examination and photographic documentation, measured using the ImageJ® software after standardizing the wound area scale. Complete healing will be defined as full epithelialization of the target lesion, with no exudate and no need for dressing. This proportion will be observed in each intervention and control group, allowing for comparison among the four study groups (control, CCLF2023, GCLF2023, and NDLF2023) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the time to complete healing (in days), considering the interval between randomization and the date when the wound is fully epithelialized. This outcome will be verified through statistical analysis using Kaplan-Meier survival curves and the log-rank test for comparison between groups. Differences in healing time will be observed across control and intervention groups;To evaluate wound progression in terms of healing phases over the 14-week follow-up period. This outcome will be verified through weekly clinical assessments, classifying the wound as inflammatory, granulation, or epithelialization phase, based on standardized clinical criteria. Phase transitions will be documented through clinical records and standardized photographic evidence | — |
Countries
Brazil
Contacts
Public ContactAna Lima Alves Cerdeira
Centro de Pesquisa Clínica do Hospital Universitário da Universidade Federal do Amapá
Outcome results
None listed