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临床试验/NCT04205942
NCT04205942Unknown不适用

Cold Plasma Therapy for Acceleration of Wound Healing in Superficial, Infected Diabetic Foot

Ruhr University of Bochum0 个研究点目标入组 65 人开始时间: 2016年8月17日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
65
主要终点
change in wound surface area

研究概览

简要总结

Diabetic foot is a common complication of diabetes mellitus and requires specialized treatment. Wounds are characterized by persistent infection and chronic inflammatory processes, impeding well directed matrix remodelling and wound closure. Cold plasma applications have demonstrated beneficial effects on wound healing in several case reports. The investigator-initiated "Kaltplasma Wund (KPW)-Trial" was performed to prove beneficial effects of cold plasma in wound healing in a prospective, placebo-controlled, randomized bi-center study.

详细描述

Diabetic foot (DF) is a major complication in patients with diabetes leading to increased risk of hospitalization, lower limb amputation, and death, as well as a significant decrease in quality of life. During lifetime the risk for developing DF is assumed to be 25%; with 30% of DF resulting in lower limb amputation. If compared to general population people with diabetes have a 20-fold higher risk for amputation. Diabetes mellitus is the leading cause of lower limb amputation. Ulceration and impaired wound healing are commonly associated with common co-morbidities; the increased risk of infection amongst patients with diabetes is driving chronification and accounts for lack of wound healing.

Non-thermal atmospheric pressure plasma has been proposed as a tool for various biological and medical applications relying on its capacity to reduce bacterial load in the wound and to initiate wound healing. Biological plasma effects are largely dependent on plasma-generated reactive species in the gas phase, which subsequently diffuse or react with proteins and lipids in cells or tissues.

Thus, the objective of this placebo-controlled patient-blinded study was to show that application of cold plasma in addition to standard care treatment compared to placebo could accelerate wound healing in terms of more rapid and clinical meaningful wound surface regression. Wound closure progression and microbiological analysis were monitored time dependently to prove the effects. Patient's well-being and subjective perceptions were evaluated during treatment.

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 (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 1 or Type 2 Diabetes mellitus
  • HbA1c ≤ 10%
  • at least one chronic wound persisting for at least three weeks without healing tendency following standard care wound therapy (Armstrong Wagner Grade Ib or IIb)

排除标准

  • concomitant wound treatment with local vacuum therapy or maggot therapy
  • use of topical active antibiotics,
  • concomitant treatment with platelet rich fibrin,
  • presence of critical limb ischemia defined as ankle brachial index below 0.5 or transcutaneous oxygen pressure below 15 mmHg.
  • participation in another clinical trial
  • women of child bearing potential without effective contraception or active breastfeeding

结局指标

主要结局

change in wound surface area

时间窗: treatment period of max 15 days

change in wound surface area within 14 days treatment

change in signs of clinical infection

时间窗: treatment period of max 15 days

change in clinical signs of infections as judged by the investigator

change in microbial load

时间窗: treatment period of max 15 days

change in microbial count, being evaluated by microbial culture

次要结局

  • time to significant wound surface area change(treatment period of max 15 days)
  • total wound surface change during treatment(treatment period of max 15 days)
  • treatment related side effects - formation of keloids(treatment period of max 15 days)
  • treatment related side effects - presence of skin irritation(treatment period of max 15 days)
  • changes in Quality of life (EQ5D questionnaire)(treatment period of max 15 days)
  • changes in Quality of life (SF12 questionnaire)(treatment period of max 15 days)
  • time to change in wound infection(treatment period of max 15 days)
  • treatment related side effects - local bleeding(treatment period of max 15 days)
  • treatment related side effects - proliferative skin reaction(treatment period of max 15 days)

研究者

发起方
Ruhr University of Bochum
申办方类型
Other
责任方
Principal Investigator
主要研究者

Diethelm Tschoepe

Prof. Dr. Dr. med., Medical Director Diabetes Center at Herz- und Diabeteszentrum NRW

Ruhr University of Bochum

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