Role of electrical stimulation in enhancement of cutaneous wound healing and engraftment: Accelerated healing by secondary intention and dermal substitute-assisted tissue regeneration in cutaneous wounds

Accel-Heal® Technologies Ltd0 sites20 target enrollmentAugust 20, 2021

Overview

Phase: 未知
Intervention: Not specified
Conditions: Assessment of cutaneous wound healing in healthy volunteers with and without skin substitute using electrical stimulation
Sponsor: Accel-Heal® Technologies Ltd
Enrollment: 20
Status: Terminated
Last Updated: 3 years ago

No summary available.

Registry

who.int

Start Date

August 20, 2021

End Date

December 1, 2022

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

Accel-Heal® Technologies Ltd

•1\. Male and female subjects will be included to allow for gender demographic analysis.
•2\. Subjects of either gender who are 18 years and older.
•3\. Subjects who in the opinion of the investigator, are able to fully understand the study requirements and attend all follow\-up visits.
•4\. Subjects must provide written informed consent to participate in the study.
•5\. Subjects weighing between 40 and 150kg, with a body mass index of 20\-35kg/m2 (as described in the Quetelet’sindexQuetelet’s index – weight (kg)/height²(m)).

•1\. Subjects who do not give consent or withdraw their consent to take part in the study.
•2\. Subjects of either gender who are less than 18 years old.
•3\. Subjects who have a history of keloid scarring.
•4\. Subjects who are pregnant or planning to conceive in the next 3 months.
•5\. Subjects who have a chronic or active skin disorder which may be considered to adversely affect the healing rate of the acute wound by the investigator.
•6\. Subjects with any likely wound healing impairment due to a clinically significant medical condition such as renal, hepatic, haematological, neurological or immune disease, including:
•7\. Rheumatoid arthritis
•8\. Chronic renal impairment
•9\. Diabetes Mellitus
•10\. Significant hepatic impairment