Soreze Advance Gel for treatment of Pressure Ulcer Healing and Wound Care in Adult Subjects

A phase-IV, Open-Label, interventional, prospective, single arm Trial of Soreze Advance Gel for treatment of Pressure Ulcer Healing and Wound Care in Adult Subjects - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/12/078059

Enrollment

Registered

2024-12-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

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 Advance Gel: Soreze Advance Gel combines a natural recipe of herbs and essential oils with silicone elastomers that helps in healing of bedsores by forming a wound dressing that

Eligibility

Inclusion criteria

Inclusion criteria: 1)Subjects who are 18 years to 80 years of age (Both Years inclusive). 2)Patients who are willing and provide a signed, dated informed consent. 3)Patients who are available for follow-up. 4)The patient has one or more pressure ulcers (bedsores) (stage II or Stage III).

Exclusion criteria

Exclusion criteria: 1)The patient participating in another study, or has participated in another study in the last 28 days. 2)The patient is in an exclusion period determined by a previous study. 3)The patient refuses to sign the consent. 4)The patient is pregnant, parturient, or breastfeeding. 5)Patient under curative anticoagulation. 6)Patient is a woman of child-bearing potential and does not consent to or receive a screening urine pregnancy test prior to study enrolment. 7)Patient has any wound that at enrolment is scheduled for surgical closure within 14 days. 8)Patients having grade I & IV pressure ulcer. 9)Use of any immunosuppressant medications (for example, cyclosporine, methylprednisolone, prednisone, methotrexate, alefacept, or infliximab) within 30 days of screening.

Design outcomes

Primary

Measure	Time frame
To compare percentage change in ulcer size, stage, length, width, and depth in patients with at least one of stage II or Stage III pressure ulcer in subjectsTimepoint: Visit-1, Visit-2, Visit-3, Visit-4, Visit-5, Visit-6, Visit-7	—

Secondary

Measure	Time frame
1)To compare healing progress using the National Pressure Ulcer Advisory Panel’s Pressure Ulcer Scale for Healing (PUSH) score and other indicators of wound healing such as time to complete wound closure, elimination of signs of wound infection. 2)Safety and tolerability will be monitored by adverse events assessment (AEs and SAEs) throughout the study period.Timepoint: Visit-1, Visit-2, Visit-3, Visit-4, Visit-5, Visit-6, Visit-7	—

Measure

Time frame

1)To compare healing progress using the National Pressure Ulcer Advisory Panel’s Pressure Ulcer Scale for Healing (PUSH) score and other indicators of wound healing such as time to complete wound closure, elimination of signs of wound infection. 2)Safety and tolerability will be monitored by adverse events assessment (AEs and SAEs) throughout the study period.Timepoint: Visit-1, Visit-2, Visit-3, Visit-4, Visit-5, Visit-6, Visit-7

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Countries

India

Contacts

Public ContactDr Swati

Jawahar Lal Nehru Medical College

rakeshverma.jln@outlook.com9460077585

Outcome results

None listed

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