Diabetes Foot Care Clinical Pathway Project - Exciton Technologies Inc

NCT02990832 | Withdrawn

• 1 other identifier: AICE-201500872
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Infection assessed as per Infectious Disease Society of America (IDSA) guidelines

  Assessed as per Infectious Disease Society of America (IDSA) guidelines

  28 days

Secondary Outcomes (3)

• Pain assessed with Ordinal scale

  28 days

• Wound volume

  28 days

• Safety and complications (incidence of adverse events)

  28 days

Study Arms (1)

Exciton

EXPERIMENTAL

Treatment of diabetic foot ulcer with Exciton Exsalt wound dressing

Device: Exciton

Interventions

Exciton DEVICE

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.

Exciton

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with diabetes mellitus according to definitions outlined by the American Diabetes Association
• Presenting with a localized mild infection of the ulcer as listed in the IDSA Clinical Practice Guideline for the Diagnosis and Treatment of Diabetic Foot Infections (Table 1); exceeding 0.5 cm2 in area after appropriate debridement
• Diagnosis of mild infection must be confirmed immediately following debridement at Baseline
• Subject must agree to adhere to all protocol procedures and must be willing and able to provide written informed consent.
• Correction or optimization of underlying medical problems (e.g. diabetes or systemic infection).
• Wound has been identified as stalled or persistent non-healing under current standard-of-care; showing no progression in 2 weeks as per IDSA guidelines

You may not qualify if:

• Use of systemic antibiotics within the previous 2 weeks
• Known silver sensitivity
• Current use of enzymatic debridement
• Wounds where best practice wound bed preparation is not available or applicable (eg, wound with diminutive oxygen supply would be contraindicated for debridement.
• No palpable dorsalis pedis or posterior tibial pulse or a pedal systolic pressure (Doppler) of ≤ 40 mm Hg
• Evidence of systemic infection (fever, chills, hypotension)/sepsis
• Non-study systemic or anti-infective topical agents

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Innovates Health Solutions: collaborator
• Exciton Technologies Inc.: collaborator

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 13, 2016
• Study Start: January 1, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: April 29, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share