MPPT – Frontiers in Medicine
New MPPT clinical study:
100% closure rate of pressure ulcers

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Pressure ulcers

A pressure ulcer is localised injury to the skin and/or underlying tissue as a result of inappropriate pressure – intense or prolonged pressure or pressure in combination with shear. It usually occurs over bony prominences. Pressure ulcers frequently lead to the development of osteomyelitis (bone infection). Osteomyelitis more than 6 weeks old can only be removed by surgery, but the re-occurrance rates are high.

Pressure ulcers respond poorly to existing wound treatments, but Amicapsil has been shown in clinical trials to be effective in treating and closing pressure ulcers.

Petition for Amicapsil

See petition to have Amicapsil available via the NHS.

Clinical study: Amicapsil in pressure ulcers

Study performed in collaboration with Stoke Mandeville and Salisbury:

  • 100% closure rate for acute and chronic pressure ulcers.
  • In wounds resulting from osteomyelitis, i.e. draining fistulas, soft tissue infection was removed. This led to reduced wound size, reduced risk of sepsis, and improved well-being.
  • Bed rest not required.
  • Treatment was delivered by telemedicine (mobile health). The approach was successful and well received.

Real-world-evidence confirms study

Damian Smith from the patient organisation SIA (Spinal Injuries Association) confirmed the findings in an independent survey. It found (see survey):

  • 100% closure rate for wounds and pressure ulcers.
  • Clinical meaningful improvement of all draining fistulas, e.g. reduced wound size, reductions in autonomic dysreflexia, reduced risk of sepsis, no requirement for bed rest, and improved overall health and QoL.
  • Satisfaction with Amicapsil-SCI was: 84% highly positive, 11% positive, 0% negative. 5% were uncertain whether their wounds had closed due to Amicapsil or the changed treatment regime.

What is a pressure ulcer?

A pressure ulcer is localised injury to the skin and/or underlying tissue as a result of inappropriate pressure – intense or prolonged pressure or pressure in combination with shear. It usually occurs over bony prominences. Oxygen and nutrients are carried around to all cells in the body by the blood. If any cells are deprived of this supply for too long, they die – this is called ischaemia. It is thought that a too inappropriate pressure collapses or even crushes the vessels and impede the blood supply to the cells for long enough to also kill a certain amount of soft-tissue cells in the area. This combination leads to tissue death / necrosis that cannot be rapidly contained and repaired due to the impairment of the paths that are necessary in order to carry the supplies required for restructure (the blood vessels) as well as the paths of the repair personnel (the lymph vessels). The presence of dead tissue for a too long period of time in the deeper layers of the skin and/or the underlying soft-tissue, gives rise to an inflammatory process that can spread rapidly to the surrounding tissue causing further tissue death. This inflammation is seen on the skin surface as “inexplicable” redness. At this stage it is of paramount importance to react quickly and make sure that any pressure is taken off that body area immediately and until there are no more traces of redness (usually days) as this will indicate that restructuring and healing has taken place. If the developing injury is not detected and off-loaded of any pressure at this early stage, it will break through the skin and an ulcer will have formed. Once this happens, the area will immediately be colonised by the microbes that are present on the surrounding skin and in the immediate environment. To prevent an infection and to support healing, it is important to support and maintain a balanced microbiome in the wound and surrounding area.

Pressure ulcers tend to develop quickly and are prone to infection. As the vessels in the area are involved, pressure ulcers have a high prevalence of septicaemia / blood infection or blood poisoning, i.e. bacteria and other microbes passing into the blood stream and being carried around in the entire body, including to the vital organs. As pressure ulcers often develop over bony structures, they are also often associated with osteomyelitis, i.e. infection of the bone. Also, skin infection / cellulitis is closely associated with pressure ulcers. Septicemia, osteomyelitis and cellulitis are common complications of pressure ulcers and high risk factors of developing sepsis.

Current treatment of pressure ulcers

The National Institute for Clinical Excellence (NICE) guidelines and the latest Cochrane reviews on dressings, topical treatments and NPWT (a pump using vacuum to remove wound exudate) recommend the following treatment for pressure ulcers:

1) Systemic antibiotics should not be used to treat a pressure ulcer, according to NICE.

2) Topical antiseptics or antimicrobials should not, according to NICE, be used to treat a pressure ulcer. The Cochrane review found no data to indicate that any dressing type or antimicrobial were better than saline-soaked gauze.

3) NPWT (the pump) is not recommended by NICE for routine use on pressure ulcers, except to control the exudate. The Cochrane review could find no data to support its use in pressure ulcers.

4) NICE recommends considering moist wound care (covering the wound with an occlusive dressing). However, data indicate that the moist environment will exacerbate an infection (https://www.ncbi.nlm.nih.gov/pubmed/28532812). The Cochrane review, which is more recent, did indeed find no data to support this approach.

In conclusion, there are no data to support the use of any of the existing approaches for the treatment of pressure ulcers. This is in line with the recent study by Guest et al. (2018) that only 14% of infected pressure ulcers heal within the first 12 months.

Amicapsil consistently treats pressure ulcers and the treatment is easy and inexpensive if initiated before the wound is more than 2 months old. Amicapsil is effective in immunocompromised individuals as well.