Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum

Stasis Ulcer Clinical Trial

Official title:

Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum In The Treatment Of Recalcitrant Venous Stasis Ulcers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02802995
• Other study ID #: BDU005
• Status: Terminated
• Phase: Phase 3
• First received: May 17, 2016
• Last updated: October 24, 2017
• Start date: May 2016
• Est. completion date: May 2017

Study information

• Verified date: June 2016
• Source: University of Witwatersrand, South Africa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to

• To evaluate the safety and tolerability of Platelet Rich plasma(PRP)/Thrombin mixture in treating chronic venous ulcers

• To evaluate efficacy of PRP/Thrombin mixture in treating chronic venous ulcers

Description:

Study rationale

In normal wound healing, platelets activate macrophages to produce endogenous platelet derived growth factor (PDGF) and other growth factors which are responsible for would healing. In chronic wounds, macrophage activation is suppressed which leads to an inappropriate growth factor response causing failure of positive autocrine feedback loop which normally controls the healing process. The regular application of exogenous PRP and Thrombin, to chronic wounds, restores the autocrine feedback loop of tissue repair which appears to accelerate the normal cascade of tissue repair

Objectives

• To evaluate the safety and tolerability of PRP/Thrombin mixture in treating chronic venous ulcers

• To evaluate efficacy of PRP/Thrombin mixture in treating chronic venous ulcers

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Willing and able to give written informed consent

• Age 18 years to 75 years.

• Both males and females.

• Ankle branchial index of 0.8 or above.

Exclusion Criteria:

• Diabetics will be excluded as the Ankle Branchial Index (ABI) result is considered an unreliable due the possible presence of arteriosclerotic plaques (lead pipe rigidity).

• Patients who have participated in experimental drug studies within 30 days of entering this study.

• receiving chemotherapy or radiotherapy for malignant diseases or any other indication

• Patients taking corticosteroids or other immunosuppressive medications

• Clinically malnourished patients or those with recent (last 4 weeks without treatment) serum albumin of less than 30g/l.

• Patients with current or past history of acute deep vein thrombosis.

• Patients with current signs and/or symptoms of cardiac, renal or hepatic failure. Renal failure defines as Creatinine

• Patients with signs and/or symptoms of peripheral neuropathy.

• Patients with signs and/or symptoms of ATROPHIE BLANCHE or other conditions associated with non-chronic venous insufficiency ulceration of the lower leg.

• Patients with signs and/or symptoms of immunocompromized sates or recent (last 4 weeks ) T cell subset (CD4) count of less than 200 cells / ml.

• Patients showing clinical signs and/or symptoms of anaemia or current or recent(last 4 weeks without treatment) haemoglobin level of less than 8g/dl

Related Conditions & MeSH terms

• Stasis Ulcer
• Varicose Ulcer

Intervention

Drug:
• PRP/thrombin mixture
Mixture of platelet rich plasma and thrombin applied topically on the wound surface

Locations

Country	Name	City	State
South Africa	Charlotte Maxeke Johannesburg Academic Hospital	Johannesburg	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

References & Publications (14)

Atri SC, Misra J, Bisht D, Misra K. Use of homologous platelet factors in achieving total healing of recalcitrant skin ulcers. Surgery. 1990 Sep;108(3):508-12. — View Citation

Callam MJ, Ruckley CV, Harper DR, Dale JJ. Chronic ulceration of the leg: extent of the problem and provision of care. Br Med J (Clin Res Ed). 1985 Jun 22;290(6485):1855-6. — View Citation

Dolynchuk K, Keast D, Campbell K, Houghton P, Orsted H, Sibbald G, Atkinson A. Best practices for the prevention and treatment of pressure ulcers. Ostomy Wound Manage. 2000 Nov;46(11):38-52; quiz 53-4. Review. — View Citation

Franz RC. Platelet concentrate-thrombin coagulum: a new biological dressing for the promotion of wound healing. S Afr Med J. 1987 Dec 5;72(11):810-1. Erratum in: S Afr Med J 1988 Jan 23;73(2):137. — View Citation

Franz RW, Shah KJ, Halaharvi D, Franz ET, Hartman JF, Wright ML. A 5-year review of management of lower extremity arterial injuries at an urban level I trauma center. J Vasc Surg. 2011 Jun;53(6):1604-10. doi: 10.1016/j.jvs.2011.01.052. Epub 2011 Apr 8. — View Citation

Hammermeister KE, Johnson R, Marshall G, Grover FL. Continuous assessment and improvement in quality of care. A model from the Department of Veterans Affairs Cardiac Surgery. Ann Surg. 1994 Mar;219(3):281-90. — View Citation

Hess CT. Pressure ulcer evidence-based treatment pathway integrated with evidence-based decisions: part 3. Adv Skin Wound Care. 2013 Sep;26(9):432. doi: 10.1097/01.ASW.0000434207.28117.5d. — View Citation

Phillips LG, Mann R, Heggers JP, Linares HA, Robson MC. In vivo ovine flap model to evaluate surgical infection and tissue necrosis. J Surg Res. 1994 Jan;56(1):1-4. — View Citation

Pierce GF, Brown D, Mustoe TA. Quantitative analysis of inflammatory cell influx, procollagen type I synthesis, and collagen cross-linking in incisional wounds: influence of PDGF-BB and TGF-beta 1 therapy. J Lab Clin Med. 1991 May;117(5):373-82. — View Citation

Pierce GF, Mustoe TA, Altrock BW, Deuel TF, Thomason A. Role of platelet-derived growth factor in wound healing. J Cell Biochem. 1991 Apr;45(4):319-26. Review. — View Citation

Roe DF, Gibbins BL, Ladizinsky DA. Topical dissolved oxygen penetrates skin: model and method. J Surg Res. 2010 Mar;159(1):e29-36. doi: 10.1016/j.jss.2009.10.039. Epub 2009 Nov 21. — View Citation

Steed DL, Ricotta JJ, Prendergast JJ, Kaplan RJ, Webster MW, McGill JB, Schwartz SL. Promotion and acceleration of diabetic ulcer healing by arginine-glycine-aspartic acid (RGD) peptide matrix. RGD Study Group. Diabetes Care. 1995 Jan;18(1):39-46. — View Citation

Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study. Diabetes Care. 1998 May;21(5):822-7. — View Citation

Wilkins RG, Unverdorben M. Wound cleaning and wound healing: a concise review. Adv Skin Wound Care. 2013 Apr;26(4):160-3. doi: 10.1097/01.ASW.0000428861.26671.41. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Size of the wound treated with the PRP/thrombin mixture	Size of the wound will be measured at the end of the study	12 weeks
Primary	Number and type adverse events	Adverse events will reported at the start and throughout the treatment period	12 weeks