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Cold Plasma Therapy for Acceleration of Wound Healing in Diabetic Foot

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04205942
Enrollment
65
Registered
2019-12-20
Start date
2016-08-17
Completion date
2024-04-30
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot

Brief summary

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.

Detailed description

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.

Interventions

DEVICEArgon Plasma Jet

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.

DEVICEPlacebo

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.

Sponsors

Ruhr University of Bochum
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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)

Exclusion criteria

* concomitant wound treatment with local vacuum therapy or maggot therapy * dialysis * 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

Design outcomes

Primary

MeasureTime frameDescription
change in signs of clinical infectiontreatment period of max 15 dayschange in clinical signs of infections as judged by the investigator
change in wound surface areatreatment period of max 15 dayschange in wound surface area within 14 days treatment
change in microbial loadtreatment period of max 15 dayschange in microbial count, being evaluated by microbial culture

Secondary

MeasureTime frameDescription
time to change in wound infectiontreatment period of max 15 dayschange in wound infection over treatment
changes in Quality of life (EQ5D questionnaire)treatment period of max 15 daysEvaluation of life quality during (EQ5D questionnaire) treatment period via questionaire
changes in Quality of life (SF12 questionnaire)treatment period of max 15 daysEvaluation of life quality during (SF12 questionnaire) treatment period via questionaire
time to significant wound surface area changetreatment period of max 15 daystime to 10% reduction of wound surface compared to treatment start
total wound surface change during treatmenttreatment period of max 15 daystotal wound surface change compared to treatment start
treatment related side effects - formation of keloidstreatment period of max 15 daysquestion to evaluate potential side effects of the therapy: formation of keloids will be answered in a yes or no fashion and reported
treatment related side effects - presence of skin irritationtreatment period of max 15 daysquestion to evaluate potential side effects of the therapy: presence of skin irritation will be answered in a yes or no fashion and reported
treatment related side effects - local bleedingtreatment period of max 15 daysquestion to evaluate potential side effects of the therapy: local bleeding will be answered in a yes or no fashion and reported
treatment related side effects - proliferative skin reactiontreatment period of max 15 daysquestion to evaluate potential side effects of the therapy: proliferative skin reaction will be answered in a yes or no fashion and reported

Other

MeasureTime frameDescription
treatment related side effects - formation of keloidswithin 5 years after start of treatment (at 1, 2 and 5 years after start of treatment)descriptive evaluation of side effects within 5 years after Treatment (at 1, 2 and 5 years after start of treatment) question to evaluate potential side effects of the treatment: formation of keloids will be answered in a yes or no fashion and reported
treatment related side effects - presence of skin irritationwithin 5 years after start of treatment (at 1, 2 and 5 years after start of treatment)question to evaluate potential side effects of the therapy: presence of skin irritation will be answered in a yes or no fashion and reported
treatment related side effects - proliferative skin reactionwithin 5 years after start of treatment (at 1, 2 and 5 years after start of treatment)question to evaluate potential side effects of the therapy: proliferative skin reaction will be answered in a yes or no fashion and reported
treatment related side effects - local bleedingwithin 5 years after start of treatment (at 1, 2 and 5 years after start of treatment)question to evaluate potential side effects of the therapy: local bleeding will be answered in a yes or no fashion and reported

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026