Intervention Period for Leg Ulcer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Leg Ulcer+12 More
NanoSALV Catalytic - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The goal of this clinical trial is to assess the impact that the NanoSALV wound dressing can have on managing severe chronic wounds and feasibility for patients, providers, and health systems in different health care settings (community care, continuing care and in-patient care). The main questions it aims to answer are: What is the cost-savings of using NanoSALV? Do care providers perceive NanoSALV to be better, worse or the same as the standard of care in terms of usability and efficiency? Does NanoSALV increase autonomy and competence of wound self-management for care providers/patients? Were patients more satisfied, less satisfied or just as satisfied with NanoSALV compared to the standard of Care? Does NanoSALV reduce healing time for chronic wounds compared to standard of care? The sequence and duration of the trial is as follows: Required data will be collected at enrollment to provide a baseline (Day 0) measure. The patient will receive standard of care treatment for four weeks with dressing changes as per the standard care pathway. In the following four weeks the patient will receive the NanoSALV dressing treatment and dressing changes done every 48 - 72 hours as required. Wound assessments will be done weekly with wound images captured by Aranz Medical's Silhouette Star 3D medical camera that digitally takes measurements. A patient satisfaction survey will be collected post-control and post-intervention periods One week after completing the study the patient/surrogate will be contacted or a survey link will be sent to them regarding adverse events and to see what wound dressing they continued to use. Semi-structured interviews and observations will be done with care providers/patients and healthcare professionals in the control period to explore the perspectives on the current state of chronic wound management, and in the intervention period to evaluate the perceptions on the usability of the intervention.

Eligible Conditions
  • Diabetic Foot Ulcers (DFUs)
  • Pressure Injury Stage III
  • Pressure Injury
  • Pressure Injury Stage IV
  • Venous Leg Ulcer (VLU)
  • Pressure Injury Stage 2
  • Leg Ulcer

Treatment Effectiveness

Study Objectives

5 Primary · 7 Secondary · Reporting Duration: Through study completion over four months

Day 56
Patient satisfaction - comfort
Patient satisfaction - ease of use
Patient satisfaction - overall satisfaction
Through study completion over four months
Adverse events
Process Improvement
Quality Improvement
Soft Cost Savings
User Experience
User Satisfaction
Week 8
Patient preference
Wound percent area change
Wound percent volume change

Trial Safety

Trial Design

2 Treatment Groups

Control Period
1 of 2
Intervention Period
1 of 2
Active Control
Experimental Treatment

95 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention Period · No Placebo Group · N/A

Intervention Period
Device
Experimental Group · 1 Intervention: NanoSALV Catalytic · Intervention Types: Device
Control PeriodNoIntervention Group · 1 Intervention: Control Period · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion over four months

Who is running the clinical trial?

Chester Ho, MDLead Sponsor
Alberta Health servicesOTHER
143 Previous Clinical Trials
305,439 Total Patients Enrolled
NanoTess Inc.UNKNOWN

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 18 years or over.
You are able to comply with standard of care practices as per the type of wound.
The person's care plan must include the use of topical silver or iodine dressings or other ointments/solutions.
You have a pressure injury to the skin or soft tissue.
You are able to comply with the study requirements.
Patients may be admitted to the hospital if the length of stay is <4 days and they are not admitted to the ICU.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 10th, 2021

Last Reviewed: October 21st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.