Chronic diabetic foot ulcers Circulatory System Chronic diabetic foot ulcers
Conditions
Interventions
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) plu
Sponsors
Adtec Europe Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 5. Ulcers with dimension 1.0cm2 – 30cm2 6. Ulcer where there is less than 40% decrease in wound surface area in the previous 4 weeks 7. Ulcer has not been present for more than 2 years 8. If foot pulses not palpable the toe brachial pressure index (TBPI) should be greater than 0.5 9. If TBPI cannot be assessed then the ankle brachial pressure index (ABPI) should be 0.8 or above 10. If ABPI is 1.3 or above the Doppler sounds should be at least biphasic Original inclusion criteria: 1. Aged 18 years and over 2. 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 inflammation 4.2. Inflammation extends less than 2cm from the wound 4.3. Infection is limited to skin/soft tissue 4.4. Systemically well 5. Ulcers with dimension 1.0cm2 – 30cm2 6. Ulcer where there is less than 40% decrease in wound surface area in the previous 4 weeks 7. Ulcer has not been present for more than 2 years 8. Adequate blood supply determined by palpable foot pulses or if not palpable a TBPI greater than 0.7 9. Loss of protective sensation to a 10g monofilament 10. Male or female
Exclusion criteria
Exclusion criteria: 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) 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 feeding 7. Women who are of child-bearing age not using reliable contraception 8. TBPI less than 0.5 9. ABPI less than 0.8 10. If ABPI above 1.3 and vessel sounds are monophasic 11. Those who have clinical evidence of gangrene at any location 12. Those who has a medical condition that in the opinion of the investigator would make the patient an inappropriate candidate for the study 13. Those who have necrotic toes on the study ulcer foot 14. Those who have undergone surgical procedure other than debridement on the study ulcer foot within 3 weeks prior to screening 15. Study ulcer over active Charcot’s joint 16. Non study ulcer within 5.0 cm from the study ulcer at enrolment 17. 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 diseases 3. 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 wound 4.3. Lymphangitis 4.4. Localised necrosis/ gangrene 4.5. 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 feeding 7. Women who are of child-bearing age not using reliable contraception 8. TBPI less than 0.7 9. Those who have clinical evidence of gangrene at any location 10. 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 study 11. Those who have necrotic toes on the study ulcer foot 12. Those who have undergone surgical procedure other than debridement on the study ulcer foot within 3 weeks prior to screening 13. Study ulcer over active Charcot’s joint 14. Non study ulcer within 5.0 cm from the study ulcer at enrolment 15. Participation in other clini
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound volume is measured using digital photographic imaging that will record, and measure the wound bed tissue type, wound dimensions and wound volume at baseline, 1, 2, 3 and 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The effect of gas plasma in regards to accelerated healing is measured using wound tissue biopsy’s and wound slough samples taken from the 60 patients at baseline and week 4 2. Presence of biofilms is measured as the numbers of bacteria and comparison to bacteria quantified from the wound surface, using wound tissue biopsy’s and wound slough samples, at baseline and week 4 3. Microbial populations are measured using digital photographic imaging, at baseline week 1, week 2, week 3, week 4 as well as wound tissue biopsy and wound slough samples at baseline and week 4 | — |
Countries
England, United Kingdom
Contacts
Public ContactMary McGovern
Outcome results
None listed