Primary Objective: 1. To investigate the safety of cold plasma plaster treatment of diabetic foot ulcers. Secondary Objective(s): 1. To investigate the effect of cold plasma plaster treatment of diabetic foot ulcers on bacterial load.2. To…
ID
Source
Brief title
Condition
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety of cold plasma plaster treatment in diabetic foot ulcers. Cold plasma
plaster treatment is considered safe when in * 10% serious adverse advents
grade other than infection occur due to treatment within 30 days after the last
application of cold plasma, and if * 60% of patients need treatment for
infection with surgery or systemic antibiotics within 30 days after the last
treatment.
Secondary outcome
* The effect of cold plasma plaster treatment on bacterial load is considered
clinically significant if bacterial load is reduced with 50% at day 10 compared
to day 1 as measured by deep tissue swab, and 50% reduction in bacterial load
before and directly after cold plasma plaster treatment on day 1, 5 and 10.
* Healing of the wound, defined as full epithelialization, at 2 and 12 weeks
after start of treatment.
* Occurrence of clinically defined infection according to the International
Working Group on the Diabetic Foot/Infectious Diseases Society of America*s
classification [15,16] during treatment and after treatment.
* Clinical outcome (amputation, death, treatment with antibiotics) 3 months
after enrolment.
* Quality of life 3 months after enrolment measured with questionnaires
(PAID-NL, SF-36, USER-P).
Background summary
Diabetic foot ulcers are common complications of diabetes mellitus and greatly
increase the risk of infection or subsequent amputation. A novel method to
decrease the likelihood of infection and to help cure ulcers are non-thermal or
cold plasmas. These are shown in vitro to kill a wide range of pathogenic
bacteria and to increase proliferation of fibroblasts and other cells,
promoting the wound healing process.
Study objective
Primary Objective:
1. To investigate the safety of cold plasma plaster treatment of diabetic foot
ulcers.
Secondary Objective(s):
1. To investigate the effect of cold plasma plaster treatment of diabetic foot
ulcers on bacterial load.
2. To investigate the effect of cold plasma plaster treatment of diabetic foot
ulcers on wound healing.
Study design
Pilot observational study in 20 patients with diabetic foot ulcers.
Intervention
Patients will be treated on an outpatient basis with daily cold plasma
treatment for 10 days in 2 weeks. Other than cold plasma, standard protocols
for wound treatment will be deployed, including wound care and proper
offloading.
Study burden and risks
Most of the interventions are standard interventions in patients with diabetic
foot ulcers. These include blood samples, X-ray, wound cultures, biomechanical
offloading and regular wound debridement at weekly or two-weekly clinic visits.
Additional to standard care are 10 short visits to the clinic to receive
treatment in the first two weeks. Also, patients are asked to fill in
questionnaires and additional quantitative wound cultures will be taken on day
1, 5 and 10. The intervention with cold plasma has been tested in animals and
in other wound patients. Expected risks include subsequent infection, skin
sensations (e.g. paresthesia, pain, heat) which in previous studies ranged from
no to mild symptoms that were deemed acceptable by non-neuropathic subjects. We
expect skin sensations to be virtually absent in our subjects with neuropathy.
De Boelelaan 1117
Amsterdam 1081HV
NL
De Boelelaan 1117
Amsterdam 1081HV
NL
Listed location countries
Age
Inclusion criteria
- Type 1 or 2 diabetes mellitus
- Foot ulcer with a maximum depth of 5 millimeters, without evidence of bone or joint tissue in the wound base, without overt clinical infection (University of Texas Wound Classification A1, A2, C1 or C2)
- Able and willing to comply with the research protocol.
Exclusion criteria
- Implanted electrical medical devices such as cardiac pacemakers
- Life-threatening cardiac conductivity abnormality
- Active malignancy
- Pregnant or lactating women
- Women of childbearing age not using contraceptive measures
- A foot infection needing antibiotic treatment
- Patients with deep wounds (> 5 millimeters) or with bone or joint tissue in the wound base.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 21784 (candidate number NTR) |
| CCMO | NL51274.029.15 |