Comparative clinical study between treatment with papain gel 2% and 10% in patients with lower limb ulcers.

Randomized double blind clinical trial, comparing treatment with papain gel 2% and 10% in patients with lower limb ulcers.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REBEC

Registry ID

RBR-2gj78z9

Enrollment

Unknown

Registered

2022-07-06

Start date

2018-08-29

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

Leg ulcer

Interventions

The clinical study of non-inferiority followed the methodology called Consolidated Standards of Reporting Trials - CONSORT (2010), and the number of participants was determined by using the data packa

VS2.002.001.005

G16.762.891

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with lower limb ulcers; aged 18 or over; male or female; who agreed to participate voluntarily in the research

Exclusion criteria

Exclusion criteria: Patients under 18 years old; with ulcers with malignant transformation (cancer); arterial disease; osteomyelitis

Design outcomes

Primary

Measure	Time frame
To evaluate the effectiveness of healing using the formulation HGPU10 (hydrogel, papain 10% and urea) versus HGPU2 (hydrogel, papain 2% and urea) guided by the clinical tool of healing Push Tool. Result: The achievement of the primary outcome, healing, occurred in 35 patients, more than half of the sample, being in relation to measures of effectiveness between the fifth and twelfth weeks of ulcer healing, in both groups, 12 in the group control and 06 in the intervention. All 62 evolved without intercurrences or adverse events during treatment.	—

Measure

Time frame

To evaluate the effectiveness of healing using the formulation HGPU10 (hydrogel, papain 10% and urea) versus HGPU2 (hydrogel, papain 2% and urea) guided by the clinical tool of healing Push Tool. Result: The achievement of the primary outcome, healing, occurred in 35 patients, more than half of the sample, being in relation to measures of effectiveness between the fifth and twelfth weeks of ulcer healing, in both groups, 12 in the group control and 06 in the intervention. All 62 evolved without intercurrences or adverse events during treatment.

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Secondary

Measure	Time frame
Evaluate clinical signs of superficial and deep infection when applying the acronym NERDS / STONES, selectivity of papain in viable tissue (granulation and reeptelization) and adverse events, including pain according to visual analog scale (EVA). Result: Regarding the selectivity of the formulation with 10% papain, it was confirmed throughout the healing process, as well as a more effective proteolytic action in relation to the formulation with 2% papain. Control of clinical signs of superficial and deep wound infection occurred in almost 100% of patients (N=60) at the last evaluation. It is worth mentioning that, among chronic patients, the effectiveness of controlling the clinical signs of infection with both formulations determines the non-inferiority of papain 10%. About pain, it was rarely mentioned, being higher in the papain group 2% (43.8%) and lower in the 10% (23.3%) group, a situation that may be related to other intervening variables not analyzed in the study. In 100% of the patients, there were no adverse events to the treatment.	—

Measure

Time frame

Evaluate clinical signs of superficial and deep infection when applying the acronym NERDS / STONES, selectivity of papain in viable tissue (granulation and reeptelization) and adverse events, including pain according to visual analog scale (EVA). Result: Regarding the selectivity of the formulation with 10% papain, it was confirmed throughout the healing process, as well as a more effective proteolytic action in relation to the formulation with 2% papain. Control of clinical signs of superficial and deep wound infection occurred in almost 100% of patients (N=60) at the last evaluation. It is worth mentioning that, among chronic patients, the effectiveness of controlling the clinical signs of infection with both formulations determines the non-inferiority of papain 10%. About pain, it was rarely mentioned, being higher in the papain group 2% (43.8%) and lower in the 10% (23.3%) group, a situation that may be related to other intervening variables not analyzed in the study. In 100% of the patients, there were no adverse events to the treatment.

—

Countries

Brazil

Contacts

Public ContactKarina Di Piero

Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro

comeip@hucff.ufrj.br+55-021-39386244

Outcome results

None listed

Source: REBEC (via WHO ICTRP)