Cold Plasma Therapy for Acceleration of Wound Healing in Diabetic Foot

Diabetic Foot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04205942
• Other study ID #: KPW2016-1.1
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 17, 2016
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2023
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: April 30, 2024
• Est. primary completion date: April 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

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

Related Conditions & MeSH terms

• Diabetic Foot

Intervention

Device:
• Argon 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.
• Placebo
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	treatment related side effects - formation of keloids	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	within 5 years after start of treatment (at 1, 2 and 5 years after start of treatment)
Other	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	within 5 years after start of treatment (at 1, 2 and 5 years after start of treatment)
Other	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	within 5 years after start of treatment (at 1, 2 and 5 years after start of treatment)
Other	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	within 5 years after start of treatment (at 1, 2 and 5 years after start of treatment)
Primary	change in wound surface area	change in wound surface area within 14 days treatment	treatment period of max 15 days
Primary	change in signs of clinical infection	change in clinical signs of infections as judged by the investigator	treatment period of max 15 days
Primary	change in microbial load	change in microbial count, being evaluated by microbial culture	treatment period of max 15 days
Secondary	time to significant wound surface area change	time to 10% reduction of wound surface compared to treatment start	treatment period of max 15 days
Secondary	total wound surface change during treatment	total wound surface change compared to treatment start	treatment period of max 15 days
Secondary	time to change in wound infection	change in wound infection over treatment	treatment period of max 15 days
Secondary	changes in Quality of life (EQ5D questionnaire)	Evaluation of life quality during (EQ5D questionnaire) treatment period via questionaire	treatment period of max 15 days
Secondary	changes in Quality of life (SF12 questionnaire)	Evaluation of life quality during (SF12 questionnaire) treatment period via questionaire	treatment period of max 15 days
Secondary	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	treatment period of max 15 days
Secondary	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	treatment period of max 15 days
Secondary	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	treatment period of max 15 days
Secondary	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	treatment period of max 15 days