Treatment of Diabetic Foot Ulcers With Inforatio Technique to Promote Wound Healing: a Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Refusal rates
研究概览
简要总结
This trial will examine the feasibility of conducting a definitive randomized clinical trial that tests whether inforatio technique will reduce time to healing of diabetic foot ulcers. Inforatio technique is a procedure where small punch biopsies are taken from the wound bed near the edge of the wound. With this technique, the investigators wish to initiate an acute inflammatory response that increases the generation of granulation tissue with subsequent healing by scar formation. Thus, the investigators hypothesize that inforatio technique will promote healing of diabetic foot ulcers.
Based on clinical experience, the investigators have previously detected a reduction in time to healing as an unexpected effect when multiple punch biopsies are taken from the wound bed of diabetic foot ulcers. To the knowledge of the investigators, methods similar to the inforatio technique has not previously been studied.
详细描述
BACKGROUND
The prevalence of diabetic foot ulcers is expected to increase considerably due to a continuously increasing prevalence of diabetes. The healing process of diabetic foot ulcers is complicated by a complex pathophysiology of the distal lower extremities and a constant exposure to bacteria and pressure. Improving healing of diabetic foot ulcers will have several benefits including higher quality of life, reduced morbidity, reduced mortality and lower socioeconomic costs. Nonetheless, there are few randomized controlled clinical trials on surgical and non-surgical treatment chronic foot ulcers and many studies on the topic have a low level of evidence.
TRIAL AIMS
The investigators aim to assess the feasibility of conducting a definitive randomized controlled trial by exploring recruitment, patient acceptability, protocol adherence and adverse effects.
The success criteria of the trial is as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Feasibility trial group
Every trial patient will receive the intervention (the inforatio technique) that is intended for the definitive randomized clinical trial.
干预措施: Inforatio technique (Procedure)
结局指标
主要结局
Refusal rates
时间窗: The first 2 months of the trial (untill the last patient has been recruited)
Descriptive statistics of number and rate of eligible patients that refuse trial participation.
Eligibility rates
时间窗: The first 2 months of the trial (untill the last patient has been recruited)
Descriptive statistics of number and rate of eligible patients during the period of recruitment
Time from identification to inclusion
时间窗: The first 2 months of the trial (untill the last patient has been recruited)
Descriptive statistics of average time from eligible patients are identified to they are included in the trial (baseline trial visit)
Qualitative assessment of patient acceptability
时间窗: 10 months
Assessed by interviews with participants.
Qualitative assessment of the extent of qualitative patient measures
时间窗: 10 months
The investigators assess whether the qualitative patient measures are either too extensive or insufficient. Thus, estimating necessary changes to make the qualitative measurements feasible to include in the future definitive trial.
Rates of wound treatments at trial visits that deviate from the trial standard treatment definition
时间窗: 10 months
Standard treatments received by each patient at the follow-up visits are recorded and it is assessed whether the standard care received corresponds to the definition of the trial standard treatment.
Time to healing of the foot ulcers
时间窗: 10 months
The investigators will report mean and variance of time to healing
Patient-reported experience of trial participation and the inforatio technique
时间窗: 10 months
The investigators will interview the patient about their experience of trial participation and of the inforatio technique.
Qualitative assessment of unexpected factors that must cause exclusion
时间窗: 10 months
Qualitatively assessed by the primary investigator
Rate of unexpected exclusion
时间窗: 10 months
Descriptive statistics of number and rate of patients that are excluded due to reasons not already covered by the trial definition of exclusion criteria.
Retention rates
时间窗: 10 months
To investigate protocol adherence, the number and rate of participants that adhere to follow-up will be reported.
Patient-reported potential side effects
时间窗: 10 months
A qualitatively assessment of harms and unexpected effects by interviewing participants about potential side effects that they experience.
Qualitative assessment of logistics issues regarding outpatient clinic visits
时间窗: 10 months
The investigators qualitatively assesses logistic circumstances that may be optimized.The assessment includes whether dates of follow-up visits fit the routines at the outpatient clinics.
Time to healing of punch biopsy scars
时间窗: 10 months
The time to healing will be reported to estimate if and when observer blinding may be possible.
Number of missed trial follow-up visits
时间窗: 10 months
To investigate protocol adherence, the number of missed trial visits will be reported for each participant.
Drop-out rates
时间窗: 10 months
To investigate protocol adherence, the number and rate of participants that choose to drop out during follow-up will be reported.
Rate of eligible patients that accept participation
时间窗: At baseline, each follow-up visit and when patients drop out.
A quantitative investigation of patient acceptability.
Observed harms and unexpected effects
时间窗: 10 months
Observed harms and unexpected effects observed by the investigators and staff will be reported.
Qualitative assessment of wound care treatments received between trial visits and the deviations from the trial definition of standard treatment.
时间窗: 10 months
The investigators assess the heterogeneity of treatment during follow-up by recording the number of hospital visits between the trial follow-up visits and the treatments and assessments received at these hospital visits.
Qualitative assessment of the method of wound assessment.
时间窗: 10 months
The investigators assess complications related to the method wound bed area and the depth. The aim is to optimize wound assessment for the future definitive trial.
Qualitative assessment of the feasibility of culturing 3 biopsies from each round of inforatio technique applications for a future definitive trial.
时间窗: 10 months
The investigators assess whether the included centers have the capacity to culture three biopsies two times from each patient.
Qualitative assessment of the inforatio technique
时间窗: 5 months. At baseline application and at the 21-day applications.
The method of inforatio technique application will be qualitatively assessed by the applicant. The applicant will report any issues or complications regarding the inforatio technique definition.
Staff acceptability
时间窗: 10 months
Assessed qualitatively by interviews with the staff at the outpatient clinics (wound care nurses and podiatrists)
次要结局
未报告次要终点