Health Condition 1: L978- Non-pressure chronic ulcer of other part of lower leg Health Condition 2: L979- Non-pressure chronic ulcer of unspecified part of lower leg
Conditions
Interventions
Intervention1: Theruptor Sterile Barrier Wound Dressing: 3-D Spacer fabric made of Polyethylene Terephthalate (90% w/w) & Polyurethane (10% w/w) +
1% w/w of DTAC
Dimethyl Tetradecyl[3-(trimethoxysilyl)propyl] ammonium chloride.
Applied twice weekly at an interval of 3 to 4 days.
For 8 weeks.
Control Intervention1: Bactigrass wound dressing: Cotton leno-weave
Sponsors
CareNow Medical Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female of age 18 years or older. 2.Patients wound must be chronic (either dibetic or non diabetic) in orgin and larger than 1 cm square . Non diabetic wound will include venous and pressure ulcers.Patients presenting with 2 or more signs of infection (pain, erythema, warmth, swelling, discharge and malodour), but with reduced bacterial bioburden will be recruited for Diabetic and non diabetic wounds. 3.Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study. 4.The age of the wound between 3 months and one year, with documented failure of prior treatment to heal the wound will be selected. 5.Patient has adequate circulation to the affected extremity, as demonstrated by one of the following in case of Diabetic and non diabetic ulcers, within the past 60 days: (For all patients) Doppler ABI result gretaer than or equal to 0.7 and less than or equal to 1.2 Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg.
Exclusion criteria
Exclusion criteria: 1.Patients presenting with a wound probing to bone (UT Grade IIIAD). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe. 2.Patients whose index foot ulcers are greater than 25cm2 for diabetic wounds and greater than 50 cm2 for non diabetic wounds. 3.Patients with a known history of poor compliance with medical treatments. 4.Patients who have been previously randomized into this study, or are presently participating in another clinical trial. 5.Patients who are currently receiving radiation therapy or chemotherapy. 6.Patients with known or suspected local skin malignancy to the index ulcer. 7. Serum Creatinine more than 2 mg/dl and HbA1c more than 10% 8. Non-revascularizable surgical sites. 9. Patient who are pregnant or breastfeeding. 10.Patient who are taking medications that are considered immune system modulator 11.Allergy to the test or comparator products employed in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in Wound area and healing rate will be assessed weekly using digital Vernier Caliper and compared between the treatment groups. 2. Reduction in bacterial load. Microbiological assessment of wound with swab test, assessment of capacity of the dressing to inhibit organisms prone to biofilm production. 3. Improvement in clinical signs and symptoms of chronic wounds (pain, erythema, warmth, swelling, discharge and malodour) will be assessed at each dressing change.Timepoint: Day 1,7,14,21,28,42 and 56 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The Percentage of wound closure rate and proportion of completely healed wounds (where ever possible) in patients treated with Theruptor Sterile Barrier Wound Dressing versus comparator dressings will be assessed. 2. Exudate management and wound bleeding during each dressing change. 3. Maceration, Erythema grading scale, wound pain assessment, Red Yellow Black wound assessment scale, Condition of surrounding skin area, percentage of tissue types and systemic lab parameters will be assessed. 4.Microbiological assessment of sample wound dressings. 5. Wound-QoL and Cardiff Wound Impact Questionnaire and product performance parameters and analysis of cost of wound management will be assessed. 6. Number of adverse events, serious adverse events, device incidents and missed treatment visits will be documented for safety.Timepoint: Day 1,7,14,21,28,42 and 56 | — |
Countries
India
Contacts
Public ContactDr Uma Narayanamurthy
All India Institute of Medical Sciences
Outcome results
None listed