Healing action of green propolis in increasing the number of cells and their migration and evaluation of healing activity in patients with wounds on the lower limbs caused by Leprosy

In vitro effect of green propolis on cell proliferation and migration and clinical evaluation of its healing activity in patients with ulcers in the lower limbs resulting from Leprosy

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-2k228rg

Enrollment

Unknown

Registered

2024-05-08

Start date

2021-07-16

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leprosy sequelae [leprosy]

Interventions

A pilot, selected, blinded and controlled clinical study was carried out to evaluate the efficacy of the investigational product under investigation. This study met all stages of the Research Committe

D20.215

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients of both sexes; age over 18; already treated and cured of leprosy; who had lower limb wounds with an area between 3 and 75 square centimeters

Exclusion criteria

Exclusion criteria: People allergic to propolis; patients diagnosed with critical ischemia or who have had a serious uncontrolled infection

Design outcomes

Primary

Measure	Time frame
Primary expected outcome: It is expected to find an effect of propolis on tissue repair with a reduction in the area of ??the lesion evaluated through lesion morphometry.;Primary outcome found: Propolis ointment reduced the area of ??the lesion, culminating in tissue repair, determined through morphometry done at the beginning of the study and at the end of the study.	—

Secondary

Measure	Time frame
Expected secondary outcomes: determine in which phase of tissue repair the propolis ointment has the greatest potential for action, through analysis of the inflammatory cytokines involved in tissue repair and observe the exsudate reduction and improvement of the morphological appearance of the wound, evaluated through Pressure Ulcer Scale for Healing (PUSH) scale.;Secondary outcomes found: it was verified through the analysis of inflammatory cytokines involved in tissue repair, that propolis action is more intense in the initial phase of treatment, influencing the cellular and chemical events of the inflammatory and proliferative phases of tissue repair. It was also found that propolis favors the formation of a more revitalized granulation tissue and promotes the reduction of inflammatory exudate, determined through the application of the Pressure Ulcer Scale for Healing PUSH.	—

Measure

Time frame

Expected secondary outcomes: determine in which phase of tissue repair the propolis ointment has the greatest potential for action, through analysis of the inflammatory cytokines involved in tissue repair and observe the exsudate reduction and improvement of the morphological appearance of the wound, evaluated through Pressure Ulcer Scale for Healing (PUSH) scale.;Secondary outcomes found: it was verified through the analysis of inflammatory cytokines involved in tissue repair, that propolis action is more intense in the initial phase of treatment, influencing the cellular and chemical events of the inflammatory and proliferative phases of tissue repair. It was also found that propolis favors the formation of a more revitalized granulation tissue and promotes the reduction of inflammatory exudate, determined through the application of the Pressure Ulcer Scale for Healing PUSH.

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Countries

Brazil

Contacts

Public ContactCristiano Rosa

Universidade São Francisco

cristiano.rosa@usf.edu.br+55(35)998586820

Outcome results

None listed

Source: REBEC (via WHO ICTRP)