Safety Evaluation of the DiaSole Insole With Diabetic Foot Ulcers.

NCT05604352 | Unknown

• 1 other identifier: CVT001_Protocol
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Offloading plays an important part Diabetic foot ulcers healing. The modular design of the DiaSole would allow the offloading cavity to be changed in line with the changing ulcer dimensions. It may be possible to use the DiaSole for other causes of neuropathic foot ulcerations (such as rheumatoid arthritis), but the safety of the insole needs assessing first. There is already evidence to support the use of offloading insoles in the healing and prevention of pressure ulcers, DiaSole may be an improved insole for this purpose.

Conditions

Diabetes Mellitus Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Assessing the safety of the DiaSole insole

  Recording adverse events

  8-weeks per patient

Secondary Outcomes (2)

• Clinical efficacy of DiaSole insole

  8-weeks per patient

• acceptability of DiaSole to health care professionals (HCPs)

  8-weeks per patient

Study Arms (1)

Main study

EXPERIMENTAL

Study to investigate the safety and clinical efficacy of the DiaSole insole.

Device: DiaSole

Interventions

DiaSole DEVICE

Diabetic ulcer offloading insole

Main study

Eligibility Criteria

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

You may qualify if:

• Age 18 years and above
• Capacity to consent
• UK Shoe size 3-11
• Diagnosis of Diabetes
• Sensory neuropathy (lack of perception of 10g monofilament in one or more sites of the feet)
• Active foot ulceration (plantar aspect), grade 1a using the University of Texas wound grading system (grade 1a)
• Appropriate footwear (which has room to safely accommodate the DiaSole insole)
• At risk of ulceration or re-ulceration (Grade 0A)

You may not qualify if:

• Patients who are non-concordant and do not have appropriate footwear that could house the DiaSole insole
• Clinical signs of or confirmed active infection (soft tissue or osteomyelitis)
• History of or active Charcot foot or severe foot deformity
• Amputation
• Critical limb ischemia or diagnosed moderate to severe peripheral arterial disease
• Inappropriate footwear (does not accommodate the DiaSole insole)
• Visual impairment (cannot see feet and footwear properly)
• Sensory neuropathy of the upper limbs/hands
• History of drug and alcohol abuse• Have known contraindications to the materials used in the product insoles. Allergies to cotton or silicone
• Have an infectious disease, which may pose as a potential risk to the researchers and clinicians
• Are enrolled into another study
• Unable to attend regular hospital visits - e.g. housebound
• Are unwilling to take part in the study
• Are currently enrolled in any other research
• Individuals who do not adequately understand verbal explanations of written information in English, unless there is access to a qualified translator

Sponsors & Collaborators

• Kaydiar Ltd: lead

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

Central Study Contacts

David J Barton, BSc(hons)

CONTACT

07552140218; david@kaydiar.co.uk

Heather M Smart, BSc(hons)

CONTACT

07548676623; heathermairesmart@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single sample, no randomisation, no blinding.

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 3, 2022
• Study Start: January 1, 2023
• Primary Completion: April 28, 2023
• Study Completion: May 15, 2023
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share