Diabetic Foot
Conditions
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
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.
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| change in signs of clinical infection | treatment period of max 15 days | change in clinical signs of infections as judged by the investigator |
| change in wound surface area | treatment period of max 15 days | change in wound surface area within 14 days treatment |
| change in microbial load | treatment period of max 15 days | change in microbial count, being evaluated by microbial culture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to change in wound infection | treatment period of max 15 days | change in wound infection over treatment |
| changes in Quality of life (EQ5D questionnaire) | treatment period of max 15 days | Evaluation of life quality during (EQ5D questionnaire) treatment period via questionaire |
| changes in Quality of life (SF12 questionnaire) | treatment period of max 15 days | Evaluation of life quality during (SF12 questionnaire) treatment period via questionaire |
| time to significant wound surface area change | treatment period of max 15 days | time to 10% reduction of wound surface compared to treatment start |
| total wound surface change during treatment | treatment period of max 15 days | total wound surface change compared to treatment start |
| treatment related side effects - formation of keloids | treatment period of max 15 days | question 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 irritation | treatment period of max 15 days | 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 - local bleeding | treatment period of max 15 days | question 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 reaction | treatment period of max 15 days | question to evaluate potential side effects of the therapy: proliferative skin reaction will be answered in a yes or no fashion and reported |
Other
| Measure | Time frame | Description |
|---|---|---|
| treatment related side effects - formation of keloids | within 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 irritation | within 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 reaction | within 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 bleeding | within 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 |