Health Condition 1: L97- Non-pressure chronic ulcer of lower limb, not elsewhere classified
Conditions
Interventions
Intervention1: Seriderm: Silk protein-based advanced wound care product. Seriderm will be applied to the patient at baseline visit. Dressing will be changed after 3-7 days. The frequency of dressing c
Sponsors
Serigen Mediproduct Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male and female between the ages of 21 and 80 that are able to provide informed consent, are available for weekly clinic visits and are willing to comply with off- loading requirements of treatment; If diabetic, have been on a stable dose of medication to treat diabetes for less than 30 days; Target DFU surface area between 1 cm2 and 30 cm2, following debridement DFU duration between 1 and 24 months Have a DFU that has been present for at least 30 days Clean wounds, classified as either Clean (C), Clean-Contaminated (CC), as per NHSN criteria No local clinical infection (as defined by IDSA/IWGDF criteria) for any wound (target DFU or not) on lower limbs Wounds with adequate arterial blood supply in the target limb DFU grade I-C or II- C as defined by the University of Texas Diabetic Wound Classification Adequately debrided with no slough
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of ulcer closed 4vweeksTimepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of ulcers that achieved 50% or greater closure rate within 6 weeksTimepoint: 6 weeks;Wound closure rate after treatment with SeridermTimepoint: 6 weeks;Percent Wound Area Reduction (PWAR) over 6 weeksTimepoint: 6 weeks;Change in subject reported pain levels using the 0-10 Numerical Pain ScaleTimepoint: Every visit;The type and number of serious adverse events experiencedTimepoint: 6 weeks;Change in granulation tissue as assessed by the treating clinicianTimepoint: 6 weeks/ every visit | — |
Countries
India
Contacts
Public ContactDr Rucha Deshpande
Serigen Mediproducts Pvt Ltd
Outcome results
None listed