Health Condition 1: null- non-healing chronic pressure or venous stasis ulcers
Conditions
Interventions
Intervention1: Sureheal Cream and Sureheal Sterile Particles: After wound irrigation with normal saline, a medium to thick layer of Sureheal Cream would be applied and then Sureheal Sterile Particles
Sponsors
Dr Reddys Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Non-healing non-infective ulcer of 4 weeks or more duration (there can be superficial colonization/infection of the ulcer bed but no surrounding cellulitis or systemic signs of infection Not responding to regular conventional treatment Any location Non-healing pressure or venous stasis ulcer; Minimum length of the longest diagonal distance of the ulcer be 4.0 cm or more Inpatient or outpatient Able to give informed consent
Exclusion criteria
Exclusion criteria: Known history of hypersensitivity to any of the Sureheal Cream/ Sterile Particles ingredients Any associated infections; uncontrolled diabetes (defined as a HbA1C of >7% at screening) or any other uncontrolled systemic infections Patients with moderate to severe hepatic impairment (defined as increase in serum bilirubin, SGOT & SGPT by >2.5 times the upper reference level of the laboratory values) and renal impairment (defined as increase in serum creatinine and Blood urea nitrogen by >2.5 times the upper reference level of the laboratory values) Patients having severe anemia defined as an hemoglobin value of 7 gm% or less Patients who are immune compromised including but not limited to systemic corticosteroid use or chemotherapy during the 30 days prior to surgery organ transplantation autoimmune disease or HIV infection (inhaled corticosteroids are not exclusionary) Pregnant or lactating women Participation within 30 days before the start of this study in any experimental drug or device study or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated Unable to participate in the study for any reason in the opinion of the Principal Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean change in PUSH 3.0 scores from Baseline to the End of Study Visit (Week 8 or 12) for the Sureheal group compared to the placebo group. Timepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound evaluation using clinical assessment and photographyTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Dilip Pawar
Dr. Reddys laboratories Ltd.
Outcome results
None listed