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Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum

Primary Purpose

Stasis Ulcer

Status

Terminated

Phase

Phase 3

Locations

South Africa

Study Type

Interventional

Intervention

PRP/thrombin mixture

About this trial

This is an interventional treatment trial for Stasis Ulcer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Charlotte Maxeke Johannesburg Academic Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment arm

Control arm

Arm Description

Subjects receiving the study drug which is PRP/thrombin mixture

Subjects receiving the standard of care for chronic venous wounds

Outcomes

Primary Outcome Measures

Size of the wound treated with the PRP/thrombin mixture

Size of the wound will be measured at the end of the study

Number and type adverse events

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02802995

First Posted

May 17, 2016

Last Updated

October 24, 2017

Sponsor

University of Witwatersrand, South Africa

1. Study Identification

Unique Protocol Identification Number

NCT02802995

Brief Title

Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Terminated

Why Stopped

Resource issue

Study Start Date

May 2016 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Witwatersrand, South Africa

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stasis Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment arm

Arm Type

Experimental

Arm Description

Subjects receiving the study drug which is PRP/thrombin mixture

Arm Title

Control arm

Arm Type

No Intervention

Arm Description

Subjects receiving the standard of care for chronic venous wounds

Intervention Type

Drug

Intervention Name(s)

PRP/thrombin mixture

Other Intervention Name(s)

thrombostim

Intervention Description

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

Primary Outcome Measure Information:

Title

Size of the wound treated with the PRP/thrombin mixture

Description

Size of the wound will be measured at the end of the study

Time Frame

12 weeks

Title

Number and type adverse events

Description

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Johnny Mahlangu, MBBCH, MMed

Organizational Affiliation

Univeristy of the Witwatersrand

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charlotte Maxeke Johannesburg Academic Hospital

City

Johannesburg

State/Province

Gauteng

ZIP/Postal Code

2193

Country

South Africa

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

3924283

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. doi: 10.1136/bmj.290.6485.1855.

Results Reference

background

PubMed Identifier

11889736

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.

Results Reference

background

PubMed Identifier

3686285

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. No abstract available. Erratum In: S Afr Med J 1988 Jan 23;73(2):137.

Results Reference

background

PubMed Identifier

21477966

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.

Results Reference

background

PubMed Identifier

8147609

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. doi: 10.1097/00000658-199403000-00008.

Results Reference

background

PubMed Identifier

23958876

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. No abstract available.

Results Reference

background

PubMed Identifier

8277759

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. doi: 10.1006/jsre.1994.1001.

Results Reference

background

PubMed Identifier

2045423

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. doi: 10.1002/jcb.240450403.

Results Reference

background

PubMed Identifier

2019792

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.

Results Reference

background

PubMed Identifier

20097370

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.

Results Reference

background

PubMed Identifier

7698046

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. doi: 10.2337/diacare.18.1.39.

Results Reference

background

PubMed Identifier

9589248

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. doi: 10.2337/diacare.21.5.822.

Results Reference

background

PubMed Identifier

23507692

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.

Results Reference

background

PubMed Identifier

2396195

Citation

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.

Results Reference

result

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Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum

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