None listed
Conditions
Brief summary
We plan to determine if, a topical wound gel (Plurogel®), commonly used in chronic wounds and burn wounds, is effective in reducing the amount of bacteria in chronic non-healing diabetic foot wounds, and what effect it may have on the rate of wound healing . By analysing the microbial wound burden prior to treatment start, we will be able to determine what effect the Plurogel has on planktonic (free floating bacteria) and wound biofilm. We will do this using real-time qPCR and 16S rRNA, to identify and quantify the bacterial to human DNA ratio. Scanning electron microscopy will be used to observe the mean amout of biofilm as a reflective marker of intervention efficacy. The most common method to assess infection in a wound is to take a swab of the wound and see what, if any, bacteria grows. The available evidence suggests that taking a tissue sample from a suspected infected wound provides better information about what bacteria is present than taking a wound swab alone. The tissue sample is then provided to a laboratory for them to grow the bacteria. This is currently the standard way that all health care facilities operate. In addition, we also plan to send a piece of the tissue for testing with a new advanced molecular technique, as it has recently been found that trying to grow bacteria in a laboratory may not find all the bacteria that maybe present in a wound. This could explain why some people with high levels of bacteria in their chronic wound do not respond to the standard treatments we provide such as antibiotics and/ or wound care products. Using these new advanced methods will allow us to find all the bacteria in a wound and/or identify certain types of bacteria that don’t grow in laboratories. This may help change the way we treat infections as we can more successfully target particular bacteria, and in turn, this could potentially reduce some of the risks associated with foot infection, like amputation.
Interventions
Participants with a chronic (>6 weeks duration) diabetic foot ulcer (DFU) will have a wound hydrogel, Plurogel (Poloxamer P188) applied to their wound three times per week. Treating podiatrists will apply the Plurogel twice weekly, and the other application day will either be self-administered or undertaken by the community nursing team. This frequency of application will ensure that adequate wound coverage with the Plurogel is achieved, and it will also allow regular review of the wound.
The a
Participants with a chronic (>6 weeks duration) diabetic foot ulcer (DFU) will have a wound hydrogel, Plurogel (Poloxamer P188) applied to their wound three times per week. Treating podiatrists will apply the Plurogel twice weekly, and the other application day will either be self-administered or undertaken by the community nursing team. This frequency of application will ensure that adequate wound coverage with the Plurogel is achieved, and it will also allow regular review of the wound. The amount of Plurogel required per patient is variable. The surface area size of the DFU will detrmine the amount of Plurogel applied to each wound. Wound evaluation and wound swabs will be performed at each visit, and 3 tissue biopsies will be taken over the treatment period. The treatment period will be for a maximum of 6 weeks, or less should the wound heal prior. At the end of the study treatment period, participants will continue to receive standard treatment as is appropriate for their DFU.
Sponsors
South Western Sydney Local Health District
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Type 1 or Type 2 Diabetes Mellitus. Chronic, non-healing diabetic foot ulcer (DFU) (with or without signs of chronic infection). A neuroischemic or neuropathic DFU. ABI >0.4
Exclusion criteria
New acute diabetic foot infection requiring new antibiotic regimen. Current anticoagulation therapy such as Warfarin, Clopidogrel and INR >2.0 Currently being treated for osteomyelitis.
Outcome results
None listed