ISRCTN17491903已完成未知
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 个研究点目标入组 21 人开始时间: 2016年10月20日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 21
研究概览
简要总结
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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