Chronic Ulcer of Leg or Foot Clinical Trial
Official title:
Role of Platelet Rich Plasma in Enhancing Graft Take in Chronic Venous Ulcers
Chronic venous ulcers are considered a problem with a big morbidity impact on both the health facilities and patients, skin-grafting have shown not so perfect outcomes with such ulcers. In this study, the investigators compare combining autologous platelet rich plasma treatments with partial skin grafting in chronic ulcers, the results were compared to using only partial skin grafting, and among various types of chronic resistant ulcers.
Fourteen patients had bilateral lower limb ulcers, and 6 of them had single large ulcers as
follows; Fourteen patients with chronic venous ulcers (12 of which had bilateral ulcers, 2
had single large ulcers) Four patients, each with a single chronic post-traumatic ulcer Two
patients with bilateral chronic lymphatic ulcers.
After detailed history, physical examination and investigations (such as duplex),
- Each patient with bilateral ulcers included in the study (14 patients) received
treatment A on one ulcer and treatment B on the other ulcer.
- In case of patients with single large ulcers (6 patients), treatment A was done on one
half of the ulcer and treatment B on the other half of the ulcer (done in ulcers with an
area greater than 10 x 10 cms).
- Treatment A included pre-operative intra-lesional PRP injections in 1-week intervals for
3 times, followed by intra-operative intra-lesional injection of PRP prior to meshed
graft placement. PRP was injected into the ulcer bed and ulcer edges using a sterile
syringe.
Treatment B included only placement of meshed graft, with no PRP treatment.
- Pre-operative preparation: Ulcers were prepared by proper dressings and followed up
until acquiring a clean bed. Debridement was done as needed to obtain clean base ready
for graft placement.
- PRP preparation:
- 10 ml of blood was drawn from each patient intra operatively (autologous PRP).
- Blood was collected in sterile tubes, Anticoagulant Citrate Dextrose (ACD) was used
for anticoagulation, which is the same substance used to preserve viable platelets
in blood banks for platelet transfer.
- Tubes were centrifuged in Beckman Allerga X-12 centrifuge for 20 mins, 3000 rpm.
- Each 10 ml of blood yielded an average of 3-4 ml of PRP. Calcium gluconate was
added in a ratio of 1:10 to PRP. Post-operative assessment was carried out by
follow up clinical examination, photography and weekly biopsy samples.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT01561170 -
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|
Phase 0 | |
| Completed |
NCT01990170 -
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|
N/A |