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Stasis UlcerPhase 3NCT02802995

Safety And Efficacy Of Topical Platelet Rich Plasma And Thrombin Coagulum

A Phase 3 study testing PRP/thrombin mixture in people with Stasis Ulcer, run by University of Witwatersrand, South Africa at 1 site in South Africa.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stasis Ulcer
What is being tested?
PRP/thrombin mixture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSouth Africa
Study dates
May 2016to May 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • Charlotte Maxeke Johannesburg Academic Hospital

    Johannesburg, Gauteng, 2193

Other trials in South Africa

About this study

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

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
Read the 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
Conditions
Stasis Ulcer
Being tested
PRP/thrombin mixture
Medical subject headings
Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRP/thrombin mixtureDrug

    Also called thrombostim

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

Study groups in NCT02802995
Study groupRoleWhat they receive
Treatment armExperimentalSubjects receiving the study drug which is PRP/thrombin mixture
Receives: Drug: PRP/thrombin mixture
Control armNo interventionSubjects receiving the standard of care for chronic venous wounds

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Size of the wound treated with the PRP/thrombin mixture

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

    Measured: 12 weeks

  2. Number and type adverse events

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionMay 2017
  4. Study completionMay 2017

Why it stopped: Resource issue

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02802995
Sponsor's protocol ID
BDU005
Status last verified
Jun 2016
First submitted
17 May 2016
Last updated
26 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 3924283

  • 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.

    PubMed 11889736

  • 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.

    PubMed 3686285

  • 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.

    PubMed 21477966

  • 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.

    PubMed 8147609

  • 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.

    PubMed 23958876

  • 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.

    PubMed 8277759

  • 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.

    PubMed 2045423

  • 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.

    PubMed 2019792

  • 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.

    PubMed 20097370

  • 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.

    PubMed 7698046

  • 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.

    PubMed 9589248

  • 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.

    PubMed 23507692

  • 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.

    PubMed 2396195

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PRP/thrombin mixture in people with Stasis Ulcer, run by University of Witwatersrand, South Africa at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Resource issue). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Size of the wound treated with the PRP/thrombin mixture (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02802995, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.

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