Injury of Radial Artery at Wrist and Hand LevelECLARNCT02421081
Effect of Cell Surface Markers and Lymphoid Cell Distribution on the Arterial Tissue Repair (ECLAR)
A study testing vessel microsurgery, tendon repair and nerve microsurgery in people with Injury of Radial Artery at Wrist and Hand Level and Injury; Ulnar Artery, Hand and Wrist, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The radial and ulnar artery injuries related with the wrist cut are frequently encountered. There are many factors which are effective on the improvement of these arterial structures was repaired with microsurgical techniques. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injury of Radial Artery at Wrist and Hand Level, Injury; Ulnar Artery, Hand and Wrist
- What is being tested?
- vessel microsurgery, tendon repair and nerve microsurgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2014to Dec 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be chosen
- Older from 18 year
- Don't use any medicine
Who cannot join
- younger from 18 years
- Having another illness
- Using medicine
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University Faculty of Medicine
Melikgazi, Kayseri, 38050
Ali Eray GUNAY, resisdent, +905556493401, alieraygunay@hotmail.com
İbrahim KARAMAN, docent, 05327183353, drikaraman@gmail.com
About this study
Official title: Effect of Cell Surface Markers Like CD 34 - CD 133 - CD 309 and Lymphoid Cell Distribution on the Wrist Laceration With Radial or Ulnar Arterial Tissue Repair
The radial and ulnar artery injuries related with the wrist cut are frequently encountered. There are many factors which are effective on the improvement of these arterial structures was repaired with microsurgical techniques. Recently has begun to focus on neointimal thickening and endothelialization of the role in vascular healing and maturation made on histopathological study. In this study, the radial and ulnar artery laceration repair healing with the microsurgical anastomosis methods on blood CD34, CD133 and CD309 levels of the effect of the distribution of lymphoid cells has been investigated. The investigators think that; thus by demonstrating the positive impact that may arise; autologous endothelial progenitor cells which are obtained in patients; continuation of anastomotic patency undergoing coronary by-pass or the in hemodialysis patients with arteriovenous fistula; also ensuring the re-flow in patients with acute and chronic peripheral arterial occlusion. The investigators believe could be used for the reimplanted tissue in the limb breakage ensuring that survive.
Read the detailed description
The radial and ulnar arteries cuts that need to be urgently repaired using microsurgical techniques; after treatment failure rate is quite high among the injured. When straight cut repaired with microsurgical instruments under the microscope cut properly; can be obtained close to excellent results. However, there are many factors that impact on the arterial healing. Hypertension, hypotension, age, diabetes mellitus, obesity and female gender has negative effects on the vascular healing. In recent years, positive effects of endothelialization begun to focus on the improvement; and has been shown to endothelialization on the hematopoietic stem cells and endothelial progenitor cells CD34 and CD133 cd309 is effective. CD34 is a type 1 transmembrane protein and is known as the stem cell marker. Proliferative cells and endothelial stem cells play an important role still in the healing process after vascular incisions. These include CD133 (haematopoietic progenitor cells) and CD309 (Vasculoendotelial Growth Factor Receptor 2) is also believed to be effective. These stem cells and proliferating endothelial cells is called collectively endothelial proliferative cells (EPC). Griese et al in a study had been done on rabbits; autologous endothelial cells, obtained from peripheral blood with immunohistochemical methods, were transplanted after carotid artery intimal injury experimentally.The EPC-treated group was observed that increased endothelialization and significantly reduced neointimal hyperplasia, compared to the control group. Kawamoto et al in their study ex vivo; endothelial progenitor cells in the myocardial ischemic group, has been shown to have positive impact on the preservation of left ventricular function. In another clinical study in patients with peripheral arterial disease with ischemic limbs; increase of oxygen carried in the extremities in the study group, decrease in rest pain, increase in walk distance and had an increase in ankle-brachial index.
In the investigators study on the vessel laceration, such as CD 34, CD133 and CD309 endothelial progenitor cells and stem cells in the blood levels will show whether the effects on vascular healing. Results to be obtained; frequently encountered and the relatively high treatment costs and lead to the loss also great labor; myocardial infarction, peripheral arterial disease, ensuring the fistula opening in chronic dialysis patients, provision of limb preservation and vitality of limb replantation will open up new horizons.
- Being tested
- vessel microsurgery, tendon repair, nerve microsurgery
- Keywords
- CD34, CD133, CD309, Radial Artery, Ulnar Artery, Lymphoid Cell, blood levels, endothelial progenitor cells, stem cells
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vessel microsurgeryProcedure or surgery
Also called anastomosis, artery repair
That is a surgery ro repair artery laceration.
tendon repairProcedure or surgery
That is a surgery ro repair tendon cut.
nerve microsurgeryProcedure or surgery
That is a surgery ro repair median/ ulnar/ radial nerve cut.
| Study group | Role | What they receive |
|---|---|---|
| having arteriel cut | Active comparator | 30 patients who refer to Erciyes University emergency department because of wrist laceration with radial and/or ulnar artery incision,will be presenting to the study.All patient's flow rate will be evaluated by Doppler ultrasonography before surgery,as well as the healthy side and side of the cuts.Then 5 ml of blood samples will be taken from the systemic circulation,flowcytometric analysis of serum CD34,CD133 and CD309 levels to be measured.Then after patients received surgery,under a microscope using microsurgical techniques and polyamide suture will be held vascular repair.Patients will be assessed by Doppler ultrasonography again 4 weeks after surgery;flow velocity and vessel diameter will be measured at the anastomoses line and patient will be divided to 4 groups. Among these groups serum CD34,CD133,CD309 levels and distribution of lymphoid cells measured by immunohistochemistry; The relationship between the anastomosis opening will be evaluated statistically. Receives: Procedure: vessel microsurgery; Procedure: tendon repair; Procedure: nerve microsurgery |
| having tendon cut | Active comparator | 10 patients having similar age and sex with first group, who refer to Erciyes University emergency department because of wrist laceration without radial or ulnar artery cutting,will be taken to compare with first group.All patient's flow rate will be evaluated by Doppler ultrasonography before surgery,as well as the healthy side and side of the cuts.Then 5 ml of blood samples will be taken from the systemic circulation,flowcytometric analysis of serum CD34,CD133 and CD309 levels to be measured.Then after patients received surgery to repair tendons and/or nerves. Among these groups serum CD34,CD133,CD309 levels and distribution of lymphoid cells measured by immunohistochemistry; and will compare with first group. Receives: Procedure: tendon repair; Procedure: nerve microsurgery |
| healthy control | No intervention | 10 healty having similar age and sex with first group,controls who accept to give blood to determine normal range of serum CD34,CD133 and CD 309 will be taken to compare with first group.All patient's flow rate will be evaluated by Doppler ultrasonography.Then 5 ml of blood samples will be taken from the systemic circulation,flowcytometric analysis of serum CD34,CD133 and CD309 levels to be measured. |
What is being measured
The primary outcome is the main question the study is designed to answer.
flow velocity of vessel measure with doppler ultrasonography (cm/sn)
the patients will be divided 4 groups with flow velocity
Measured: flow velocity will measure from lacere arter distal and whole arter; pre surgery, and 4. week after surgery
CD 34 - 133 - 309 measurement with immunohistochemical techniques (piece)
CD 34 - 133 - 309 levels will be compared between groups
Measured: 6 hours after trauma
vessel diameter measure with doppler ultrasonography (cm)
the patients will be divided 4 groups with vessel diameter
Measured: vessel diameter will measure from lacere arter distal and whole arter; pre surgery, and 4. week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Injury of Radial Artery at Wrist and Hand LevelStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ali eray günay, TC Erciyes University
- Investigators
- İbrahim KARAMAN, docent, Study director, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421081
- Sponsor's protocol ID
- IKCD
- Acronym
- ECLAR
- Status last verified
- Oct 2016
- First submitted
- 14 Mar 2015
- Last updated
- 12 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: problems and solutions. Kidney Int. 2002 Oct;62(4):1109-24. doi: 10.1111/j.1523-1755.2002.kid551.x.
PubMed 12234281Glagov S, Zarins C, Giddens DP, Ku DN. Hemodynamics and atherosclerosis. Insights and perspectives gained from studies of human arteries. Arch Pathol Lab Med. 1988 Oct;112(10):1018-31.
PubMed 3052352Mattsson EJ, Kohler TR, Vergel SM, Clowes AW. Increased blood flow induces regression of intimal hyperplasia. Arterioscler Thromb Vasc Biol. 1997 Oct;17(10):2245-9. doi: 10.1161/01.atv.17.10.2245.
PubMed 9351396Guzman RJ, Abe K, Zarins CK. Flow-induced arterial enlargement is inhibited by suppression of nitric oxide synthase activity in vivo. Surgery. 1997 Aug;122(2):273-9; discussion 279-80. doi: 10.1016/s0039-6060(97)90018-0.
PubMed 9288132Dixon BS, Novak L, Fangman J. Hemodialysis vascular access survival: upper-arm native arteriovenous fistula. Am J Kidney Dis. 2002 Jan;39(1):92-101. doi: 10.1053/ajkd.2002.29886.
PubMed 11774107Szmitko PE, Fedak PW, Weisel RD, Stewart DJ, Kutryk MJ, Verma S. Endothelial progenitor cells: new hope for a broken heart. Circulation. 2003 Jun 24;107(24):3093-100. doi: 10.1161/01.CIR.0000074242.66719.4A. No abstract available.
PubMed 12821589Werner N, Junk S, Laufs U, Link A, Walenta K, Bohm M, Nickenig G. Intravenous transfusion of endothelial progenitor cells reduces neointima formation after vascular injury. Circ Res. 2003 Jul 25;93(2):e17-24. doi: 10.1161/01.RES.0000083812.30141.74. Epub 2003 Jun 26.
PubMed 12829619Griese DP, Ehsan A, Melo LG, Kong D, Zhang L, Mann MJ, Pratt RE, Mulligan RC, Dzau VJ. Isolation and transplantation of autologous circulating endothelial cells into denuded vessels and prosthetic grafts: implications for cell-based vascular therapy. Circulation. 2003 Nov 25;108(21):2710-5. doi: 10.1161/01.CIR.0000096490.16596.A6. Epub 2003 Nov 3.
PubMed 14597586Kawamoto A, Gwon HC, Iwaguro H, Yamaguchi JI, Uchida S, Masuda H, Silver M, Ma H, Kearney M, Isner JM, Asahara T. Therapeutic potential of ex vivo expanded endothelial progenitor cells for myocardial ischemia. Circulation. 2001 Feb 6;103(5):634-7. doi: 10.1161/01.cir.103.5.634.
PubMed 11156872Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, Amano K, Kishimoto Y, Yoshimoto K, Akashi H, Shimada K, Iwasaka T, Imaizumi T; Therapeutic Angiogenesis using Cell Transplantation (TACT) Study Investigators. Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial. Lancet. 2002 Aug 10;360(9331):427-35. doi: 10.1016/S0140-6736(02)09670-8.
PubMed 12241713
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cell Surface Markers Like CD 34 - CD 133 - CD 309 and Lymphoid Cell Distribution on the Wrist Laceration With Radial or Ulnar Arterial Tissue Repair
- ClinicalTrials.gov ID
- NCT02421081
- Acronym / sponsor ID
- ECLAR / IKCD
- Keywords
- CD34, CD133, CD309, Radial Artery, Ulnar Artery, Lymphoid Cell, blood levels, endothelial progenitor cells
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The radial and ulnar artery injuries related with the wrist cut are frequently encountered. There are many factors which are effective on the improvement of these arterial structures was repaired with microsurgical techniques. Recently has begun to focus on neointimal thickening and endothelialization of the role in vascular healing and maturation made on histopathological study. In this study, the radial and ulnar artery laceration repair healing with the microsurgical anastomosis methods on blood CD34, CD133 and CD309 levels of the effect of the distribution of lymphoid cells has been investigated. The investigators think that; thus by demonstrating the positive impact that may arise; autologous endothelial progenitor cells which are obtained in patients; continuation of anastomotic patency undergoing coronary by-pass or the in hemodialysis patients with arteriovenous fistula; also ensuring the re-flow in patients with acute and chronic peripheral arterial occlusion. The investigators believe could be used for the reimplanted tissue in the limb breakage ensuring that survive.
Detailed description
The radial and ulnar arteries cuts that need to be urgently repaired using microsurgical techniques; after treatment failure rate is quite high among the injured. When straight cut repaired with microsurgical instruments under the microscope cut properly; can be obtained close to excellent results. However, there are many factors that impact on the arterial healing. Hypertension, hypotension, age, diabetes mellitus, obesity and female gender has negative effects on the vascular healing. In recent years, positive effects of endothelialization begun to focus on the improvement; and has been shown to endothelialization on the hematopoietic stem cells and endothelial progenitor cells CD34 and CD133 cd309 is effective. CD34 is a type 1 transmembrane protein and is known as the stem cell marker. Proliferative cells and endothelial stem cells play an important role still in the healing process after vascular incisions. These include CD133 (haematopoietic progenitor cells) and CD309 (Vasculoendotelial Growth Factor Receptor 2) is also believed to be effective. These stem cells and proliferating endothelial cells is called collectively endothelial proliferative cells (EPC). Griese et al in a study had been done on rabbits; autologous endothelial cells, obtained from peripheral blood with immunohistochemical methods, were transplanted after carotid artery intimal injury experimentally.The EPC-treated group was observed that increased endothelialization and significantly reduced neointimal hyperplasia, compared to the control group. Kawamoto et al in their study ex vivo; endothelial progenitor cells in the myocardial ischemic group, has been shown to have positive impact on the preservation of left ventricular function. In another clinical study in patients with peripheral arterial disease with ischemic limbs; increase of oxygen carried in the extremities in the study group, decrease in rest pain, increase in walk distance and had an increase in ankle-brachial index.
In the investigators study on the vessel laceration, such as CD 34, CD133 and CD309 endothelial progenitor cells and stem cells in the blood levels will show whether the effects on vascular healing. Results to be obtained; frequently encountered and the relatively high treatment costs and lead to the loss also great labor; myocardial infarction, peripheral arterial disease, ensuring the fistula opening in chronic dialysis patients, provision of limb preservation and vitality of limb replantation will open up new horizons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| having arteriel cut | Active comparator | Procedure: vessel microsurgery, Procedure: tendon repair, Procedure: nerve microsurgery30 patients who refer to Erciyes University emergency department because of wrist laceration with radial and/or ulnar artery incision,will be presenting to the study.All patient's flow rate will be evaluated by Doppler ultrasonography before surgery,as well as the healthy side and side of the cuts.Then 5 ml of blood samples will be taken from the systemic circulation,flowcytometric analysis of serum CD34,CD133 and CD309 levels to be measured.Then after patients received surgery,under a microscope using microsurgical techniques and polyamide suture will be held vascular repair.Patients will be assessed by Doppler ultrasonography again 4 weeks after surgery;flow velocity and vessel diameter will be measured at the anastomoses line and patient will be divided to 4 groups. Among these groups serum CD34,CD133,CD309 levels and distribution of lymphoid cells measured by immunohistochemistry; The relationship between the anastomosis opening will be evaluated statistically. |
| having tendon cut | Active comparator | Procedure: tendon repair, Procedure: nerve microsurgery10 patients having similar age and sex with first group, who refer to Erciyes University emergency department because of wrist laceration without radial or ulnar artery cutting,will be taken to compare with first group.All patient's flow rate will be evaluated by Doppler ultrasonography before surgery,as well as the healthy side and side of the cuts.Then 5 ml of blood samples will be taken from the systemic circulation,flowcytometric analysis of serum CD34,CD133 and CD309 levels to be measured.Then after patients received surgery to repair tendons and/or nerves. Among these groups serum CD34,CD133,CD309 levels and distribution of lymphoid cells measured by immunohistochemistry; and will compare with first group. |
| healthy control | No intervention | –10 healty having similar age and sex with first group,controls who accept to give blood to determine normal range of serum CD34,CD133 and CD 309 will be taken to compare with first group.All patient's flow rate will be evaluated by Doppler ultrasonography.Then 5 ml of blood samples will be taken from the systemic circulation,flowcytometric analysis of serum CD34,CD133 and CD309 levels to be measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients will be chosen
- Older from 18 year
- Don't use any medicine
Key exclusion criteria (3 listed)
- younger from 18 years
- Having another illness
- Using medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vessel microsurgeryAlso: anastomosis, artery repairThat is a surgery ro repair artery laceration. | Procedure or surgery | having arteriel cut |
| tendon repairThat is a surgery ro repair tendon cut. | Procedure or surgery | having arteriel cut, having tendon cut |
| nerve microsurgeryThat is a surgery ro repair median/ ulnar/ radial nerve cut. | Procedure or surgery | having arteriel cut, having tendon cut |
Primary outcome
flow velocity of vessel measure with doppler ultrasonography (cm/sn)
Time frame: flow velocity will measure from lacere arter distal and whole arter; pre surgery, and 4. week after surgery
the patients will be divided 4 groups with flow velocity
CD 34 - 133 - 309 measurement with immunohistochemical techniques (piece)
Time frame: 6 hours after trauma
CD 34 - 133 - 309 levels will be compared between groups
vessel diameter measure with doppler ultrasonography (cm)
Time frame: vessel diameter will measure from lacere arter distal and whole arter; pre surgery, and 4. week after surgery
the patients will be divided 4 groups with vessel diameter
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2016.
- Results publication: PubMed 12234281Allon M, Robbin ML. Increasing arteriovenous fistulas in hemodialysis patients: problems and solutions. Kidney Int. 2002 Oct;62(4):1109-24. doi: 10.1111/j.1523-1755.2002.kid551.x.
- Results publication: PubMed 3052352Glagov S, Zarins C, Giddens DP, Ku DN. Hemodynamics and atherosclerosis. Insights and perspectives gained from studies of human arteries. Arch Pathol Lab Med. 1988 Oct;112(10):1018-31.
- Results publication: PubMed 9351396Mattsson EJ, Kohler TR, Vergel SM, Clowes AW. Increased blood flow induces regression of intimal hyperplasia. Arterioscler Thromb Vasc Biol. 1997 Oct;17(10):2245-9. doi: 10.1161/01.atv.17.10.2245.
- Results publication: PubMed 9288132Guzman RJ, Abe K, Zarins CK. Flow-induced arterial enlargement is inhibited by suppression of nitric oxide synthase activity in vivo. Surgery. 1997 Aug;122(2):273-9; discussion 279-80. doi: 10.1016/s0039-6060(97)90018-0.
- Results publication: PubMed 11774107Dixon BS, Novak L, Fangman J. Hemodialysis vascular access survival: upper-arm native arteriovenous fistula. Am J Kidney Dis. 2002 Jan;39(1):92-101. doi: 10.1053/ajkd.2002.29886.
- Results publication: PubMed 12821589Szmitko PE, Fedak PW, Weisel RD, Stewart DJ, Kutryk MJ, Verma S. Endothelial progenitor cells: new hope for a broken heart. Circulation. 2003 Jun 24;107(24):3093-100. doi: 10.1161/01.CIR.0000074242.66719.4A. No abstract available.
- Results publication: PubMed 12829619Werner N, Junk S, Laufs U, Link A, Walenta K, Bohm M, Nickenig G. Intravenous transfusion of endothelial progenitor cells reduces neointima formation after vascular injury. Circ Res. 2003 Jul 25;93(2):e17-24. doi: 10.1161/01.RES.0000083812.30141.74. Epub 2003 Jun 26.
- Results publication: PubMed 14597586Griese DP, Ehsan A, Melo LG, Kong D, Zhang L, Mann MJ, Pratt RE, Mulligan RC, Dzau VJ. Isolation and transplantation of autologous circulating endothelial cells into denuded vessels and prosthetic grafts: implications for cell-based vascular therapy. Circulation. 2003 Nov 25;108(21):2710-5. doi: 10.1161/01.CIR.0000096490.16596.A6. Epub 2003 Nov 3.
- Results publication: PubMed 11156872Kawamoto A, Gwon HC, Iwaguro H, Yamaguchi JI, Uchida S, Masuda H, Silver M, Ma H, Kearney M, Isner JM, Asahara T. Therapeutic potential of ex vivo expanded endothelial progenitor cells for myocardial ischemia. Circulation. 2001 Feb 6;103(5):634-7. doi: 10.1161/01.cir.103.5.634.
- Results publication: PubMed 12241713Tateishi-Yuyama E, Matsubara H, Murohara T, Ikeda U, Shintani S, Masaki H, Amano K, Kishimoto Y, Yoshimoto K, Akashi H, Shimada K, Iwasaka T, Imaizumi T; Therapeutic Angiogenesis using Cell Transplantation (TACT) Study Investigators. Therapeutic angiogenesis for patients with limb ischaemia by autologous transplantation of bone-marrow cells: a pilot study and a randomised controlled trial. Lancet. 2002 Aug 10;360(9331):427-35. doi: 10.1016/S0140-6736(02)09670-8.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
İbrahim KARAMAN, docent study director
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vessel microsurgery, tendon repair and nerve microsurgery in people with Injury of Radial Artery at Wrist and Hand Level and Injury; Ulnar Artery, Hand and Wrist, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Oct 2016. 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 Turkey (Türkiye). 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Eray GUNAY, MD,resident (+905556493401, alieraygunay@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
flow velocity of vessel measure with doppler ultrasonography (cm/sn) (time frame: flow velocity will measure from lacere arter distal and whole arter; pre surgery, and 4. week after surgery). The study lists 3 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 NCT02421081, which also lists 10 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 12 Oct 2016.