Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum

NCT02802995 | Terminated Phase 3

• 1 other identifier: BDU005
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Stasis Ulcer

Outcome Measures

Primary Outcomes (2)

• 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

• Number and type adverse events

  Adverse events will reported at the start and throughout the treatment period

  12 weeks

Study Arms (2)

Treatment arm

EXPERIMENTAL

Subjects receiving the study drug which is PRP/thrombin mixture

Drug: PRP/thrombin mixture

Control arm

NO INTERVENTION

Subjects receiving the standard of care for chronic venous wounds

Interventions

PRP/thrombin mixture DRUG

Mixture of platelet rich plasma and thrombin applied topically on the wound surface

Also known as: thrombostim

Treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Witwatersrand, South Africa: lead

Study Sites (1)

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, Gauteng, 2193, South Africa

Location

Related Publications (14)

• 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. doi: 10.1136/bmj.290.6485.1855.

  PMID: 3924283 BACKGROUND

• 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.

  PMID: 11889736 BACKGROUND

• 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. No abstract available.

  PMID: 3686285 BACKGROUND

• 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.

  PMID: 21477966 BACKGROUND

• 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. doi: 10.1097/00000658-199403000-00008.

  PMID: 8147609 BACKGROUND

• 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. No abstract available.

  PMID: 23958876 BACKGROUND

• 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. doi: 10.1006/jsre.1994.1001.

  PMID: 8277759 BACKGROUND

• 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. doi: 10.1002/jcb.240450403.

  PMID: 2045423 BACKGROUND

• 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.

  PMID: 2019792 BACKGROUND

• 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.

  PMID: 20097370 BACKGROUND

• 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. doi: 10.2337/diacare.18.1.39.

  PMID: 7698046 BACKGROUND

• 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. doi: 10.2337/diacare.21.5.822.

  PMID: 9589248 BACKGROUND

• 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.

  PMID: 23507692 BACKGROUND

• 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.

  PMID: 2396195 RESULT

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Johnny Mahlangu, MBBCH, MMed

  Univeristy of the Witwatersrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: June 16, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)