In vitro evidence

The LeucoPatch® triple layer structure.

Fibrin
Platelets
Leucocytes

1

Fibrin

Provides moisture retention and structural integrity, making handling and application easy.

2

Platelets

3 billion platelets provide high growth factor levels.

3

Leucocytes

50 million leucocytes orchestrate healing and fight infection. 6 million monocytes can become macrophages or collagen producing fibrocytes.


The physical, biochemical and cellular properties of LeucoPatch® have been investigated and characterised in-vitro1.

Cell recovery

98% platelet recovery.
High leucocyte recovery.
n:10 ± 95% CI.

Growth factors

LeucoPatch® contains high levels of essential growth factors.

Bacterial killing assay

Pseudomonas Aeruginosa culture.
Bacterial kill > 99% in 90 mins.
LeucoPatch® has powerful anti-bacterial properties.

The growth factors delivered by LeucoPatch® are highly active and studies confirm that these are able to activate fibroblast cells to grow and produce collagen in-vitro. In addition, keratinocytes grow and migrate in response to LeucoPatch.

Study results support the ability of LeucoPatch to actively interact with the cellular components of the chronic wound1,2.


Fibroblast growth

LeucoPatch® promotes Fibroblast growth in vitro (±95%CI).

Collagen synthesis

LeucoPatch® facilitates collagen synthesis

Keratinocyte outgrowth

LeucoPatch® facilitates significant Keratinocyte migration and proliferation

References

  1. Lundquist R et al. Wound Repair and Regeneration 2013;21:66
  2. Thomsen K et al. American Society for Microbiology, 115th General Meeting 2015.

In vivo evidence

The performance of LeucoPatch® as a treatment for DFU was evaluated in a prospective multicentre cohort study of 39 patients with hard-to-heal Wagner grade 1-2 diabetic foot ulcers1.

Wound area change
Kaplan Meier

59% of the ulcers healed at 20 weeks and the mean time to complete healing was 11 weeks despite the average wound duration of 56.5 weeks at inclusion.


LeucoPatch® has also been evaluated in clinical studies on different types of recalcitrant wounds.

The initial pilot study2 demonstrated that LeucoPatch® can be safely and effectively prepared at the point of care and is effective in healing different types of recalcitrant wounds (Diabetic Foot Ulcers, Venous Leg Ulcers and Maleolar wounds).

Wound area change
  • 13 wounds (12 patients); 6 weeks of treatment
  • Average wound duration ~ 3 years (34 months)
  • At 6 weeks, 65% wound area reduction, 4 patients completely healed
  • 46% were healed at 14 weeks follow-up

In an ongoing case series LeucoPatch® is being evaluated on diabetic foot ulcers with probe to bone (≥Wagner grade 3), current results are shown3.

Complete wound healing
  • Series of 26 ulcers in 22 patients treated with LeucoPatch®
  • Median ulcer duration was 26 weeks
  • Median number of treatments was 8
  • Bone was covered in 18 ulcers
  • 15 healed (58%) with complete epithelialization
Reapplix is committed to continuing to undertake evidence based clinical research. Ongoing 
work includes a Randomised Controlled Trial of LeucoPatch® for diabetic foot ulcers (250 patients in up to 35 centers in UK, Denmark and Sweden) to build further data on healing rates and to further capture cost effectiveness information4.

References: 

  1. Löndahl, et al. (2015). Journal of Wound Care, 24(4), 172–178.
  2. Jørgensen et al. (2011). The International Journal of Lower Extremity Wounds
  3. Fagher et al. (2015). Poster, 7th International Symposium on the Diabetic Foot (ISDF).
  4. Leucopatch System in the Management of Hard-to-Heal Diabetic Foot Ulcers.

For more information visit leucopatchtrial.org

Top