Skip to content

safety and effectiveness of Soreze gel in pressure ulcer

A clinical study to evaluate the safety, tolerability and effectiveness of Soreze gel in existing Grade 1 pressure ulcers.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034297
Enrollment
12
Registered
2021-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: L899- Pressure ulcer of unspecified site

Interventions

Intervention1: Soreze Gel: Soreze Gel Soreze is a skin protectant gel and a soothing composition of silicone elastomers, polysiloxane and starch that uses patented EPB (Elastomer Potentiated Bar

Sponsors

Amaterasu Lifesciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 18 YEARS AND ABOVE POPULATION

Exclusion criteria

Exclusion criteria: The length of stay counting from first day of admission in one or (if the patient is transferred to another ward) more participating wards. Were terminally ill or receiving chemotherapy Presence of diabetes both Type I and II Were allergic to the components of a study product Had peripheral vascular disease

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events such as erythema, itching, and pain will be evaluated. ï?·Degrees of overall satisfaction with the treatment using visual analog scale (VAS) Timepoint: Visit 1, Visit 2, Visit 3,Visit 4, Visit 5,Visit 6

Secondary

MeasureTime frame
1.No worsening of grade 1 ulcers after 21 days of treatment assessed using Braden scale. 2.No formation of grade 1 ulcers in other bed sore prone areas using Braden scale. 3.Use of local management pressure system 4.Time a patient spent during the day in a recumbent/semi-recumbent position and seated in a chair 5.Frequency of repositioning Timepoint: At Visit1, Visit 2, Visit 3, Visit 4,Visit 5

Countries

India

Contacts

Public ContactMaharukh T Rustomjee

AMATERASU LIFESCIENCES LLP

maharukh@amaterasu.in9820228088

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026