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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
65
Cold Plasma (CP) therapy is applied in the first week of treatment on a daily schedule, in the second week CP is applied every second day. In total, 8 applications are performed with a one day schedule variance.
Sham Cold Plasma (sham-CP) (switched off Electric field, no plasma production, just gas) therapy is applied in the first week of treatment on a daily schedule, in the second week sham-CP is applied every second day. In total, 8 applications are performed with a one day schedule variance.
change in wound surface area
change in wound surface area within 14 days treatment
Time frame: treatment period of max 15 days
change in signs of clinical infection
change in clinical signs of infections as judged by the investigator
Time frame: treatment period of max 15 days
change in microbial load
change in microbial count, being evaluated by microbial culture
Time frame: treatment period of max 15 days
time to significant wound surface area change
time to 10% reduction of wound surface compared to treatment start
Time frame: treatment period of max 15 days
total wound surface change during treatment
total wound surface change compared to treatment start
Time frame: treatment period of max 15 days
time to change in wound infection
change in wound infection over treatment
Time frame: treatment period of max 15 days
changes in Quality of life (EQ5D questionnaire)
Evaluation of life quality during (EQ5D questionnaire) treatment period via questionaire
Time frame: treatment period of max 15 days
changes in Quality of life (SF12 questionnaire)
Evaluation of life quality during (SF12 questionnaire) treatment period via questionaire
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Time frame: treatment period of max 15 days
treatment related side effects - formation of keloids
question to evaluate potential side effects of the therapy: formation of keloids will be answered in a "yes" or "no" fashion and reported
Time frame: treatment period of max 15 days
treatment related side effects - presence of skin irritation
question to evaluate potential side effects of the therapy: presence of skin irritation will be answered in a "yes" or "no" fashion and reported
Time frame: treatment period of max 15 days
treatment related side effects - local bleeding
question to evaluate potential side effects of the therapy: local bleeding will be answered in a "yes" or "no" fashion and reported
Time frame: treatment period of max 15 days
treatment related side effects - proliferative skin reaction
question to evaluate potential side effects of the therapy: proliferative skin reaction will be answered in a "yes" or "no" fashion and reported
Time frame: treatment period of max 15 days