Health Condition 1: L979- Non-pressure chronic ulcer of unspecified part of lower leg Health Condition 2: L088- Other specified local infections of the skin and subcutaneous tissue Health Condition 3: L894- Pressure ulcer of contiguous siteof back, buttock and hip
Conditions
Interventions
Intervention1: SILK PROTEIN-based dressing (Seriderm): Silk Protein-based dressing is an non-adherent, absorbent wound dressing intended to be used for treatment of chronic ulcers such as diabetic ulc
Sponsors
Serigen Mediproduct Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females between the ages of 18 and 80 who can provide informed consent are willing to comply with the visit schedule. 2.Subject with acute/ chronic wounds including but not limited to Diabetic foot ulcer (DFU), Venous stasis ulcers (VSU), surgical wounds/ donor site wounds/ pressure ulcers, etc. 3. Diabetic: If diabetic, have been on a stable dose of Medication to treat diabetes for less than 30 days. Have a DFU that has been present for at least 30 days. 4. Wounds with adequate arterial blood supply in the target limb DFU grade I-A or II-A as defined by the University of Texas Diabetic Wound Classification 5. Have a VSU that has been present for at least 60 days. 6. Clean wounds are classified as Clean (C) and Clean-Contaminated (CC), per NHSN criteria. 7. It adequately debrided with no slough.
Exclusion criteria
Exclusion criteria: 1. Severe debility 2. Patients on ventilator support 3. Are pregnant or lactating. 4. Have a known allergy or are sensitive to silk proteins. 5. Have liver function tests or kidney function tests that are significantly elevated. 6. Have a known or suspected disease of the immune system. 7. Have had surgery in the past 30 days to increase blood flow into your leg or foot. 8. Have cancer or a connective tissue disease (i.e. lupus, rheumatoid arthritis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of ulcers closed at 12 weeks. (Complete wound closure is to be defined as 100% re-epithelialization of the ulcer surface without drainage or dressing requirements, as confirmed at two consecutive study visits two weeks apart). The essential phases have been covered.Timepoint: 12 weeks with monitoring at every visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of ulcers that achieved 50% or greater closure rate within six weeksTimepoint: 6 weeks;Comparison of closure rates for each treatment group, Comparison of rates of wound closure between Standard of Care and SILK PROTEINSTimepoint: 12 weeks;Percent Wound Area Reduction (PWAR) over 12 weeks. The Change in percentage wound reduction (PWVR) over 12 weeks for each treatment groupTimepoint: 12 weeks;Change in reported Pain Levels between each treatment groupTimepoint: 12 weeks;The type and number of serious adverse events experiencedTimepoint: 12 weeks;Change in granulation tissue as assessed by the treating clinicianTimepoint: 12 weeks;Comparing the wound photographs before and after using silk protein dressingTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Rucha Deshpande
Serigen Mediproducts Pvt Ltd
Outcome results
None listed