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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Mrs Mary McGovern
+44 208 737 5500
clinical@adtec.eu.com


Study Location:

St James’s Hospital
Leeds Teaching Hospital NHS Trust Beckett Street
Leeds
LS9 7TF


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Efficacy of non-thermal gas plasma on sub-clinical wound infection (biofilm) in patients with diabetic ulcers

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Chronic diabetic foot ulcers


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




Background and study aims
People living with diabetes often have to live with long-term complications of the disease. One of the most common, disabling and costly complications are foot ulcers which do not heal. Infections of diabetic foot ulcers are a major cause of amputation and death. In many cases, the infection is resistant to antibiotic treatment, which can make them very difficult to treat. The infected wounds are also slow to heal due to a layer of bacteria on the surface of the wound called biofilms. Non-thermal gas plasma (NTGP) is known to be an effective and safe treatment for chronic (long term) infected wounds and does not lead to antibiotic resistance. This type of treatment consists of a five minute ‘blast’ of gas plasma held over the infected wound. The treatment head on the device contains a patented ionization chamber that bombards Argon gas (an unreactive gas) with electrons (negatively charged particles) emitted from multiple hot electric filaments. The resulting plasma ions mix with air creating reactive agents to generate a wide, constant treatment field that is capable of treating large tissue areas. The aim of this study is to find out if NTGP is an effective treatment for diabetic foot ulcers and establish a solution to a real life situation.

Who can participate?
Adults with diabetes, who have foot ulcers where healing is stalled for at least 4 weeks.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive standard wound care dressing twice per week. This involves having the wound cleaned with sterile water or normal saline (salt water) and then dressed with the usual dressing used at that site. Those in the second group also receive standard wound care dressing twice per week with the addition of NTGP. This involves five minutes of applying argon gas directly over the wound after it has been cleaned, before it is dressed. Participants in both groups have samples taken from the wound at the start of this study and then after 4 weeks in order to measure the amount of bacteria present on the surface of the wound. Photographs are also taken every week for four weeks in order to assess healing.

What are the possible benefits and risks of participating?
Participants who receive the NTGP treatment may benefit from improved quality of life as the technology should reduce stress, trauma and recovery time. There are no notable risks involved with participating.

Where is the study run from?
Leeds Teaching Hospital NHS Trust, UK
(updated 17/07/2019, previously: Salford Royal NHS Foundation Trust (UK))

When is study starting and how long is it expected to run for?
August 2016 to January 2018

Who is funding the study?
1. Innovate UK (UK)
2. Adtec Europe Limited (EU)

The healing of chronic wounds that are stalled by sub clinical wound infection (biofilm) can be accelerated following intervention with non-thermal gas plasma.


Single-centre prospective randomised controlled trial

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

06 Feb 2017

31 Dec 2020

Interventional

Intervention Type : Device
Intervention Description : Participants are randomised to one of two groups using sealed, opaque sequentially numbered envelopes (SNOSE)

Intervention group: Participants receive local standard of care wound dressing (SOCD) plus 5 minutes treatment of NTGP twice weekly over a period of 30 days (4 weeks). SOCD involves cleansing the wound with sterile water or normal saline and then dressed with the local standard of care dressing e.g. Aquacel Foam non-adhesive, Aquacel Foam adhesive, Biatain foam non adhesive, Biatain Foam adhesive. NTGP involves a two minute treatment of argon gas plasma directly over the wound.

Control group: Participants only receive local standard of care wound dressing (SOCD) twice weekly. This involves cleansing the wound with sterile water or normal saline and then dressed with the local standard of care dressing e.g. Aquacel Foam non-adhesive, Aquacel Foam adhesive, Biatain foam non adhesive, Biatain Foam adhesive.

Follow up for all study participants will occur after the 4 weeks, last samples and digital photographs will be taken at this time and participants will be informed when the results of the study will be completed and published.


You can take part if:


Inclusion criteria as of 04/04/2017:1. Male or female,2. Aged 18 years and over3. 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 inflammation4.2. Inflammation extends less than 2cm from the wound4.3. Infection is limited to skin/soft tissue4.4. Systemically well5. Ulcers with dimension 1.0cm2 – 30cm26. Ulcer where there is less than 40% decrease in wound surface area in the previous 4 weeks7. Ulcer has not been present for more than 2 years8. If foot pulses not palpable the toe brachial pressure index (TBPI) should be greater than 0.59. If TBPI cannot be assessed then the ankle brachial pressure index (ABPI) should be 0.8 or above10. If ABPI is 1.3 or above the Doppler sounds should be at least biphasic

Original inclusion criteria:1. Aged 18 years and over2. Diabetics with HbA1c less than 10% (<86mm/mol) that has been recorded within the previous 3 months.3. Foot ulcers with University of Texas grade/size A1, A2, B1 sited below the ankle including plantar, dorsal and heel ulcers.4. Diabetics whose wound/ulcer currently, or in the last 7 days, has symptoms consistent with mild diabetic foot infection (IDSA 2012)14 including:4.1. Pus or inflammation4.2. Inflammation extends less than 2cm from the wound4.3. Infection is limited to skin/soft tissue4.4. Systemically well5. Ulcers with dimension 1.0cm2 – 30cm26. Ulcer where there is less than 40% decrease in wound surface area in the previous 4 weeks7. Ulcer has not been present for more than 2 years8. Adequate blood supply determined by palpable foot pulses or if not palpable a TBPI greater than 0.79. Loss of protective sensation to a 10g monofilament10. Male or female




You may not be able to take part if:

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 diseases3. 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. Lymphangitis4.4. Localised necrosis/ gangrene 4.5. Involvement of muscle, tendon, joint or bone (active osteomyelitis)5. Those whose wound/ulcer currently has symptoms consistent with severe diabetic foot infection (IDSA, 2012) as demonstrated by:5.1. Extensive cellulitis, 5.3. Deep abscess with or without signs of systemic toxicity (fever, vomiting, hypotension, confusion, acidosis, renal failure, severe hyperglycaemia, leucocytosis) 6. Pregnant, or breast feeding7. Women who are of child-bearing age not using reliable contraception8. TBPI less than 0.59. ABPI less than 0.810. If ABPI above 1.3 and vessel sounds are monophasic11. Those who have clinical evidence of gangrene at any location12. Those who has a medical condition that in the opinion of the investigator would make the patient an inappropriate candidate for the study13. Those who have necrotic toes on the study ulcer foot14. Those who have undergone surgical procedure other than debridement on the study ulcer foot within 3 weeks prior to screening15. Study ulcer over active Charcot’s joint16. Non study ulcer within 5.0 cm from the study ulcer at enrolment17. Participation in other clinical study in the last 4 weeks

Original exclusion criteria:1. HbA1c greater than 10% (>86mm/mol)2. Those with malignancy or other immunosuppressive diseases3. Those receiving radiotherapy or medications that actively delay healing (e.g. steroids, NSAIDS, antimetabolites)4. Those whose wound/ulcer currently (or in the last 7 days) 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 wound4.3. Lymphangitis4.4. Localised necrosis/ gangrene4.5. Involvement of muscle, tendon, joint or bone (active osteomyelitis)5. Thosewhose wound/ulcer currently (or in the last 7 days) has symptoms consistent with severe diabetic foot infection (IDSA, 2012) as demonstrated by:5.1. Extensive cellulitis,5.2. Deep abscess with or without signs of systemic toxicity (fever, vomiting, hypotension, confusion, acidosis, renal failure, severe hyperglycaemia, leukocytosis)6. Pregnant, or breast feeding7. Women who are of child-bearing age not using reliable contraception8. TBPI less than 0.79. Those who have clinical evidence of gangrene at any location10. Those who have a medical condition (e.g. diabetic nephropathy) that in the opinion of the investigator would make the patient an inappropriate candidate for the study11. Those who have necrotic toes on the study ulcer foot12. Those who have undergone surgical procedure other than debridement on the study ulcer foot within 3 weeks prior to screening13. Study ulcer over active Charcot’s joint14. Non study ulcer within 5.0 cm from the study ulcer at enrolment15. Participation in other clinical study in the last 4 weeks


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • St James’s Hospital
    Leeds Teaching Hospital NHS Trust Beckett Street
    Leeds
    LS9 7TF


The study is sponsored by Adtec Europe Limited and funded by Innovate UK; Adtec Europe Limited .



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for Trial ID: ISRCTN17491903

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