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

Phase 3

• Conditions: eg ulcer; Healing; SP4.046.442.633.869.145

• Registration Number: RBR-2gj78z9
• Lead Sponsor: Hospital Universitário Clementino Fraga Filho da Universidade Federal do Rio de Janeiro

Brief Summary

Chronic ulcers of the lower limbs represent a public health problem. Affordable, effective and safe therapies should be researched, such as the papain phytomedication. Objectives: to evaluate the effectiveness of healing using the formulation HGPU10 compared to HGPU2 using the healing tool Push Tool and to clinically evaluate the signs of superficial and deep lesion infection with the acronym NERDS and STONES. Methodology: the methodology used in this study was a prospective clinical trial, single center, randomized, double-blind and non-inferiority. CAAE Research Ethics Committee 78755617.6.0000.5257 Clinical Research 283-17 group III. Results: in the period from August / 2018 to March / 2020 at the outpatient clinic of Hospital Universitário Clementino Fraga Filho - UFRJ, 101 patients were recruited, 39 of whom were excluded because they did not meet the criteria of this research and 62 were randomized to the research protocol with hydrogel papain-urea, unprecedented formulation at room temperature, in the experimental group with papain 10% (30) and control 2% (32). Regarding socio-demographic analysis, 61% women, 53% white and 66% elderly. 41 with venous ulcers and 21 neuropathic ulcers, 4 for diabetes mellitus and 17 for multibacillary leprosy, both dimorphic and virchovian. Regarding the primary outcome - healing, 35 (56%) of the 62 patients were cured. By qualitatively observing the bed of lesions of patients treated with the HGPU10 formulation, it was possible to identify the progressive evolution of viable tissues, both granulation and reeptelization, until the total healing of the lesion, not identifying setbacks in the scar evolution through the use of the formulation with greater percentage of papain (10%), being effective and safe in all stages of healing. And in relation to the secondary outcome Among the 30 patients treated with HGP10, 16% showed clinical signs of superficial infection of the lesion (NERDS), 4% showed signs of deep infection (STONES) and 80% showed no clinical signs of infection in the lesion. In the last assessment, 93% of patients no longer had clinical signs of infection.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-04-19
• Study Start: 2022-07-06
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Data analysis completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.