Inforatio Technique to Promote Wound Healing of Diabetic Foot Ulcers: a Parallel-group, Evaluator-blinded, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Complete healing
研究概览
简要总结
This randomized clinical trial will examine the effect of inforatio technique on healing of diabetic foot ulcers (DFUs).
Inforatio technique is a novel procedure developed by the research group. The definition of inforatio technique is application of small cuts in wound beds with punch biopsy tools without involving surrounding epithelia. The aim is to initiate an acute inflammatory response that will promote healing of the ulcers.
详细描述
BACKGROUND
15-25% of diabetic patients develop chronic foot ulcers - a serious comorbidity that widely affects quality of life and is associated with increased mortality and morbidity. 50-60% of DFUs become infected, and 20% of patients with infected DFUs undergo lower extremity amputation.
Inforatio technique is a novel treatment of DFUs where small cuts are made in wound beds with punch biopsy tools without involving epithelia. The aim is to cause controlled bleeding and initiate an acute inflammatory response that may promote healing.
The research group has conducted a preceding feasibility trial that showed promising results (see study by Moeini et al. in the reference list). Inforatio technique may become a supplemental treatment option for diabetic patients worldwide if it shows a beneficial effect on healing.
TRIAL AIMS
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Healing is assessed on digital ulcer images by assessors that are blinded to treatment allocation. The digital images will be blinded by the primary investigator before delivery to the assessors. Data analysts will also be blinded to treatment allocation. It is not possible to blind participants or the staff that perform wound care and clinical assessment of healing because inforatios are visible in the wound bed after application.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diabetes mellitus
- •Non-surgical ulcer located distal to the malleoli
- •Wound diameter >4 millimeters
- •Patient-reported wound duration ≥ 6 weeks
- •Only one ulcer will be included from each participant. If a patient has more than one eligible ulcer, the largest ulcer is included. In case of equally sized ulcers, the ulcer with the most recent onset is included.
排除标准
- •Dementia or other reasons that cause inability to give informed consent
- •Malignant disease
- •Current treatment with systemic immunosuppressive drugs.
- •Exclusion criteria related to the index extremity:
- •Diagnosed with or awaiting evaluation of suspected acute phase Charcot arthropathy or osteomyelitis
- •Non-palpable pulse in both arteria dorsalis pedis and arteria tibialis posterior accompanied by systolic toe pressure <30 mmHg in the index foot.
- •Amputation at midfoot level or proximal to midfoot level
- •Revascularization procedure awaits or has been undertaken within the last 8 weeks or the patient awaits a vascular surgeons' decision on revascularization
- •Exclusion criteria related to the index ulcer
- •Infection of the ulcer defined according to IWGDF/IDSA (International Working Group on the Diabetic Foot/ Infectious Diseases Society of America system) classification as presence of at least 2 of the following; 1) local swelling or induration; 2) erythema >0.5 to ≤2 cm around the ulcer; 3) local tenderness or pain; 4) local warmth; or 5) purulent discharge. Current antibiotic treatment due to infection of the index ulcer will also be considered as an ongoing infection regardless of presence of clinical signs of infection.
- •Positive probe-to-bone test
- •Exposed joint or tendon
- •The soft tissue layer covering bone or joint is evaluated to be too thin to allow for inforatio technique anywhere in the wound bed.
- •Interdigital ulcer location
研究组 & 干预措施
Control group
These participants will receive the usual care of the respective outpatient clinics.
干预措施: Usual care of the respective outpatient clinics (Other)
Intervention group
Participants that are randomized to the intervention group will receive both inforatio technique and usual care. Inforatio technique will be applied at baseline, 3, 6, 9 and 12 week- follow-up as long as the ulcers have a diameter of minimum four mms and have not developed infection, necrosis, positive probe-to-bone test, exposure of joint or tendon; or underlying osteomyelitis. In addition, inforatio technique will not be applied on ulcers that are covered by scab if the wound care staff assess that the scab should not be removed from the ulcer.
干预措施: Inforatio technique (Procedure)
Intervention group
Participants that are randomized to the intervention group will receive both inforatio technique and usual care. Inforatio technique will be applied at baseline, 3, 6, 9 and 12 week- follow-up as long as the ulcers have a diameter of minimum four mms and have not developed infection, necrosis, positive probe-to-bone test, exposure of joint or tendon; or underlying osteomyelitis. In addition, inforatio technique will not be applied on ulcers that are covered by scab if the wound care staff assess that the scab should not be removed from the ulcer.
干预措施: Usual care of the respective outpatient clinics (Other)
结局指标
主要结局
Complete healing
时间窗: 20 weeks
Healing is defined as complete epithelialization without any discharge from the site of the index ulcer. The primary outcome is the proportion of ulcers in each allocation group where healing is observed based on blinded assessment of digital images from the participants' last trial visit. The assessment of healing on digital images will be performed separately by two blinded assessors. Digital images where disagreement occurs are discussed between the assessors until agreement is reached. Any inconsistencies between the blinded assessment of healing on images and unblinded clinical assessment at trial visits will be reported. In case of death and amputation the primary outcome is registered as non-healing.
次要结局
- Change in EQ-5D-5L visual analog scale (EQ VAS) score from baseline to end of follow-up(20 weeks)
- Change in Wound-QoL global score from baseline to end of follow-up(20 weeks)