Diabetes Foot Care Clinical Pathway Project - Exciton Technologies Inc

Summary

In 2011, the premiers of all Canadian provinces and territories selected diabetes foot care as 1 of 3 significant targets for pan-provincial action. Of 210,000 people with diabetes in Alberta, 5,250 will seek treatment of a foot ulcer annually. In Alberta in 2014-15 there were 425 lower limb amputations (LLA). Moreover, there is a tremendous reduction in quality of life of the patients and attendant negative effects on their families. The 5-year mortality rate after new-onset diabetic foot ulcer is 43-55% and as high as 74% for patients undergoing LLA (CIHI, 2013). The Diabetes Foot Care Clinical Pathway Project (DFCCPP) aims to optimize methods of early detection and treatment of foot ulcers in an effort to reduce LLA by 50% by implementing High Risk Foot Teams (HRFTs) across the province starting with 3 Pilot sites. Existing staff with expertise and knowledge in diabetic foot care will assess and treat patients with moderate and high-risk findings.

In conjunction with the DFCCPP, the efficacy of a technological advancement developed by an Alberta-based small-to-medium enterprise (SME) to improve diabetic foot outcomes will be evaluated. Exsalt® SD7 Wound Dressings (Exciton Technologies, Edmonton, AB) have been demonstrated in-vitro and in-vivo to provide rapid and effective antibacterial activity in an easy-to-use format, thus creating an enhanced wound healing environment while supporting patient quality of life.

The objective of the proposed work is twofold, namely 1) to quantify clinical efficacy of exsalt® Wound Dressings on locally infected diabetic foot ulcers not progressing to healing under the current standard of care: evaluating key indicators of infection, Infectious Diseases Society of America (IDSA) wound classification, and wound size; identifying benefits to foot ulcer healing and 2) to evaluate subjective patient outcomes: satisfaction, perceived benefit, compliance. Evaluating the benefits of utilization of the Exciton exsalt® Wound Dressings when combined with the DFCCP.

Conditions

• Diabetic Foot Ulcer

Interventions

DEVICE

Exciton

Exsalt® Wound Dressings will be applied by the physician/nursing staff. The test product, exsalt® Wound Dressings (0.4 mg Ag/cm2) will be applied after wound cleansing or debridement if required. Dressings will be changed weekly, either at the out-patient facility or at home with provided dressings. At regular intervals throughout the study, as per the existing Diabetes Foot Care Clinical Care Pathway, wound assessment including size determination, Exsalt Wound Assessment Form, any adverse events will be reported, with tracing and/or photography included where available. Maximum treatment course will be 28 days (end of study) or until wound closure.

Sponsors & Collaborators

• Alberta Innovates Health Solutions

  collaborator OTHER

• Exciton Technologies Inc.

  collaborator INDUSTRY

• University of Alberta

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-31

Primary Completion

2018-05-31

Completion

2018-05-31