A randomised controlled trial to evaluate the efficacy of non-thermal gas plasma (NTGP) on sub-clinical wound infection (biofilm) in patients with diabetic foot ulcers compared to those treated with standard of care dressings

Adtec Europe Limited0 sites21 target enrollmentOctober 20, 2016

Overview

Registry

who.int

Start Date

October 20, 2016

End Date

May 31, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Adtec Europe Limited

•Inclusion criteria as of 04/04/2017:
•1\. Male or female,
•2\. Aged 18 years and over
•3\. Diabetics with HbA1c less than 10% (\<86mm/mol) (Amended 12/09/2017 to Diabetics with HbA1c less than 12% (\<108mm/mol)) that has been recorded within the previous 3 months
•4\. Foot ulcers with University of Texas grade/size A1or A2 or B1\* sited below the ankle including plantar, dorsal and heel ulcers
•\*Texas grade B1 ulcers which have symptoms consistent with mild diabetic foot infection (IDSA 2012\)14 including:
•4\.1\. Pus or inflammation
•4\.2\. Inflammation extends less than 2cm from the wound
•4\.3\. Infection is limited to skin/soft tissue
•4\.4\. Systemically well

•Exclusion criteria as of 04/04/2017:
•1\. HbA1c greater than 10% (\>86mm/mol) Amended 12/09/2017: to HbA1c greater than 12% (\>108mm/mol)
•2\. Those with malignancy or other immunosuppressive diseases
•3\. Those receiving radiotherapy or medications that actively delay healing (e.g. steroids, antimetabolites)
•4\. Those whose wound/ulcer currently has symptoms consistent with moderate diabetic foot infection (IDSA 201214\) – including
•4\.1\. Pus or inflamed wound in a patient who is systemically well and/or one of the following:
•4\.2\. Inflammation extends greater than 2cm from wound
•4\.3\. Lymphangitis
•4\.4\. Localised necrosis/ gangrene
•4\.5\. Involvement of muscle, tendon, joint or bone (active osteomyelitis)