Anal Fissure ChronicPhase 4NCT04320498
Short Term Results of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
A Phase 4 study testing prp injection, Anrecta and sitz bath in people with Anal Fissure Chronic and PRP, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
Autologous PRP currently has many uses in surgical and medical therapy. Compared with other regenerative therapies, PRP is easy-to-prepare, low-cost, and does not require complex equipment. The use of autologous PRP avoids immunological side effects. Data is lacking on the use of PRP in the treatment of anal fissure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anal Fissure Chronic, PRP
- What is being tested?
- prp injection, Anrecta and sitz bath
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 2 Jan 2021
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 18 and 65 years of age with painful defecation of at least 2 months duration and diagnosed with anal fissure between January and October 2019 were included.
- The diagnosis of chronic anal fissure required :
- the presence of internal sphincter muscle fibers in the base of the fissure
- hypertrophic anal papillae on digital rectal examination
Who cannot join
- Patients with physical examination findings that did not meet the definition of chronic anal fissure
- with painful defecation for less than 2 months,
- atypical fissure location or multiple anal fissures away from the midline
- inflammatory bowel disease
- cancer
- history of trauma
Show all 13Show fewer
- tuberculosis
- immune suppression
- sexually transmitted disease
- a disease possibly associated with a fissure
- a history of anal surgery
- previous treatment for anal fissure
- current pregnancy .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
Autologous PRP currently has many uses in surgical and medical therapy. Compared with other regenerative therapies, PRP is easy-to-prepare, low-cost, and does not require complex equipment. The use of autologous PRP avoids immunological side effects. Data is lacking on the use of PRP in the treatment of anal fissure. This study evaluated PRP as an alternative medical treatment for chronic anal fissures.
Read the detailed description
. Chronic anal fissures are mucosal ulcers in the anal canal distal to the dentate line and most often present with severe pain and bleeding during defecation. The symptoms of chronic anal fissures persist for more than 8 weeks and do not respond well to medical treatment. This randomized controlled trial investigated the effects of PRP on the healing of chronic anal fissures, which can be considered as nonhealing ulcers. High anal sphincter pressure can cause chronic anal fissures by producing mucosal ischemia in the posterior anal canal that delays wound healing, ultimately resulting in a chronic nonhealing ulcer. Increased anal sphincter pressure induces constipation and spasms in the arterioles that form the mucosal blood supply.9 Botulinum toxin, calcium channel blockers, nitrates, or surgery promote healing by reducing anal sphincter pressure, and increasing blood flow.
Autologous PRP has been shown to speed recovery and improve pain and quality of life scores of patients treated for chronic wounds.PRP reduced complaints and accelerated epithelialization and healing in patients with chronic anal fissures. PRP, which can be obtained easily and did not have any harmful patient effects may be an alternative to surgery in patients with chronic anal fissures. The duration of symptoms should be considered during the evaluation of treatment options.
- Conditions
- Anal Fissure Chronic, PRP
- Being tested
- prp injection, Anrecta, sitz bath, nutrition regulation
- Keywords
- chronic anal fissure, medical treatment, platelet rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prp injectionBiological
Also called Platelet rich plasma injection
PRP was injected locally in the anal fissure area and glyceryl trinitrate was administered twice daily in the perianal region as in the control group.
AnrectaDrug
Also called rectoderm
self-administered topical glyceryl trinitrate (anrecta), in the perianal area twice a day
sitz bathBehavioural
participants were told to take a hot water sitz bath once a day
nutrition regulationDietary supplement
The study participants were told to eat a fiber-rich diet and to drink least 2 liters of water daily
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | The control patients self-administered topical glyceryl trinitrate, in the perianal area twice a day (Anrecta, Consentis Pharmaceuticals, Istanbul, Turkey) Receives: Drug: Anrecta; Behavioral: sitz bath; Dietary Supplement: nutrition regulation |
| PRP group | Experimental | PRP was injected locally in the anal fissure area and glyceryl trinitrate was administered twice daily in the perianal region as in the control group. Receives: Biological: prp injection; Drug: Anrecta; Behavioral: sitz bath; Dietary Supplement: nutrition regulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
effects of PRP treatment on epithelization .
In a clean surgical wound, the epithelial cells migrate downward to meet deep in the dermis. Migration ceases when the layer is rejuvenated. Following surgery, this process is normally complete within 48 hours. However, the process of epithelialization is difficult in wounds that are not primarily closed or need to heal by secondary intention. In these wounds, the physical distance of epithelial migration is changed across the length, width, and depth of the wound. In chronic anal fissures, wound epithelization can be evaluated by inspection. Approximately 80 percent of the original strength of the tissue is obtained within six weeks. So we planned to make this assessment on the 10th Day, 1st Month, and 2nd Month for the reason I explained above. We considered the complete epithelization of the fissure as a complete healing. We evaluated patients with epithelialization in the midline but incomplete as partial epithelization.
Measured: 10 days , 1 month and 2 months
effect of PRP treatment on VAS scores
Distribution of the effect of PRP treatment on VAS scores. The VAS is a simple scale with a length of 100 mm on which patients were asked to rate their pain from 0 (absence of pain) to 100 (worst pain imaginable).
In connection with wound healing, we expect the pain to change. The process of epithelialization is difficult in wounds that are not primarily closed or need to heal by secondary intention. In these wounds, the physical distance of epithelial migration is changed across the length, width, and depth of the wound. So we planned to make this assessment on the 10th Day to evaluate early pain control. we planned In the first month, to evaluate the middle period pain control and in the second month to evaluate the late period pain control.
Measured: 10 days , 1 month and 2 months
Secondary outcomes (2)
effect of PRP treatment on symptoms
Distribution of the effect of PRP treatment on symptoms Presenting symptoms including constipation, pruritus, presence of skin tags, and bleeding was recorded on enrolment. In connection with wound healing, we expect symptoms such as constipation, pruritus, and bleeding to change. we assessed the decline in constipation, pruritus, and bleeding from the start of treatment. we record the symptoms of the patients on the 10th Day, the first month, and the second month. Thus, we compared the response to treatment in the early, middle, and late periods.
Measured: 10 days , 1 month and 2 months
Comparison of the effect of treatments on pain according to the onset of symptoms of patients
The duration of the associated complaints and symptoms distinguishes acute from chronic anal fissures, which are evaluated and treated as conditions with different etiologies and physiology. Acute anal fissures have symptoms of < 8 weeks duration. Chronic anal fissure symptoms have persisted for 8 weeks or longer. The effectiveness of medical treatment changes with time after the appearance of the first anal fissure symptoms and ultimately becomes less effective than surgery. we evaluated the effect of treatments on symptoms according to the onset of symptoms of patients. we evaluated VAS scores on day 10, months 1, and 2 in patients with fissures for less than 12 months than in those with fissures of longer duration.
Measured: 10 days , 1 month and 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Jan 2019
- Primary completion14 Dec 2019
- Study completion2 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Anal Fissure ChronicStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Medipol University Hospital
- Responsible party
- Principal investigator, Yusuf Tanrikulu, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320498
- Sponsor's protocol ID
- 122
- Status last verified
- Mar 2022
- First submitted
- 12 Mar 2020
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altomare DF, Binda GA, Canuti S, Landolfi V, Trompetto M, Villani RD. The management of patients with primary chronic anal fissure: a position paper. Tech Coloproctol. 2011 Jun;15(2):135-41. doi: 10.1007/s10151-011-0683-7. Epub 2011 May 3.
PubMed 21538013Gupta PJ. Closed anal sphincter manipulation technique for chronic anal fissure. Rev Gastroenterol Mex. 2008 Jan-Mar;73(1):29-32.
PubMed 18792671Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3.
PubMed 22336789Medhi B, Rao RS, Prakash A, Prakash O, Kaman L, Pandhi P. Recent advances in the pharmacotherapy of chronic anal fissure: an update. Asian J Surg. 2008 Jul;31(3):154-63. doi: 10.1016/S1015-9584(08)60078-0.
PubMed 18658016Wu PI, Diaz R, Borg-Stein J. Platelet-Rich Plasma. Phys Med Rehabil Clin N Am. 2016 Nov;27(4):825-853. doi: 10.1016/j.pmr.2016.06.002.
PubMed 27788903Dhillon RS, Schwarz EM, Maloney MD. Platelet-rich plasma therapy - future or trend? Arthritis Res Ther. 2012 Aug 8;14(4):219. doi: 10.1186/ar3914.
PubMed 22894643Li F, Li Q, Wang LF. [Advances in the research of effects of mesenchymal stem cells, exosomes, and platelet-rich plasma in wound repair]. Zhonghua Shao Shang Za Zhi. 2019 Oct 20;35(10):764-768. doi: 10.3760/cma.j.issn.1009-2587.2019.10.012. Chinese.
PubMed 31658550Etulain J, Mena HA, Meiss RP, Frechtel G, Gutt S, Negrotto S, Schattner M. An optimised protocol for platelet-rich plasma preparation to improve its angiogenic and regenerative properties. Sci Rep. 2018 Jan 24;8(1):1513. doi: 10.1038/s41598-018-19419-6.
PubMed 29367608Hancock BD. The internal sphincter and anal fissure. Br J Surg. 1977 Feb;64(2):92-5. doi: 10.1002/bjs.1800640204.
PubMed 890253EISENHAMMER S. The evaluation of the internal anal sphincterotomy operation with special reference to anal fissure. Surg Gynecol Obstet. 1959 Nov;109:583-90. No abstract available.
PubMed 13819766Notaras MJ. Lateral subcutaneous sphincterotomy for anal fissure--a new technique. Proc R Soc Med. 1969 Jul 7;62(7):713. doi: 10.1177/003591576906200737. No abstract available.
PubMed 5803521Casillas S, Hull TL, Zutshi M, Trzcinski R, Bast JF, Xu M. Incontinence after a lateral internal sphincterotomy: are we underestimating it? Dis Colon Rectum. 2005 Jun;48(6):1193-9. doi: 10.1007/s10350-004-0914-3.
PubMed 15906136Kang GS, Kim BS, Choi PS, Kang DW. Evaluation of healing and complications after lateral internal sphincterotomy for chronic anal fissure: marginal suture of incision vs. open left incision: prospective, randomized, controlled study. Dis Colon Rectum. 2008 Mar;51(3):329-33. doi: 10.1007/s10350-007-9122-2. Epub 2008 Jan 4.
PubMed 18176828Rattan S, Chakder S. Role of nitric oxide as a mediator of internal anal sphincter relaxation. Am J Physiol. 1992 Jan;262(1 Pt 1):G107-12. doi: 10.1152/ajpgi.1992.262.1.G107.
PubMed 1733256Loder PB, Kamm MA, Nicholls RJ, Phillips RK. 'Reversible chemical sphincterotomy' by local application of glyceryl trinitrate. Br J Surg. 1994 Sep;81(9):1386-9. doi: 10.1002/bjs.1800810949.
PubMed 7953427
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Platelet-rich Plasma in the Treatment of Chronic Anal Fissure
- ClinicalTrials.gov ID
- NCT04320498
- Acronym / sponsor ID
- 122
- Conditions
- Anal Fissure Chronic, PRP
- Keywords
- chronic anal fissure, medical treatment, platelet rich plasma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Collaborators
- Istanbul Medipol University Hospital
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 14 Dec 2019 (actual)
- Study completion
- 2 Jan 2021 (actual)
- First posted
- 25 Mar 2020 (actual)
- 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.
Autologous PRP currently has many uses in surgical and medical therapy. Compared with other regenerative therapies, PRP is easy-to-prepare, low-cost, and does not require complex equipment. The use of autologous PRP avoids immunological side effects. Data is lacking on the use of PRP in the treatment of anal fissure. This study evaluated PRP as an alternative medical treatment for chronic anal fissures.
Detailed description
. Chronic anal fissures are mucosal ulcers in the anal canal distal to the dentate line and most often present with severe pain and bleeding during defecation. The symptoms of chronic anal fissures persist for more than 8 weeks and do not respond well to medical treatment. This randomized controlled trial investigated the effects of PRP on the healing of chronic anal fissures, which can be considered as nonhealing ulcers. High anal sphincter pressure can cause chronic anal fissures by producing mucosal ischemia in the posterior anal canal that delays wound healing, ultimately resulting in a chronic nonhealing ulcer. Increased anal sphincter pressure induces constipation and spasms in the arterioles that form the mucosal blood supply.9 Botulinum toxin, calcium channel blockers, nitrates, or surgery promote healing by reducing anal sphincter pressure, and increasing blood flow.
Autologous PRP has been shown to speed recovery and improve pain and quality of life scores of patients treated for chronic wounds.PRP reduced complaints and accelerated epithelialization and healing in patients with chronic anal fissures. PRP, which can be obtained easily and did not have any harmful patient effects may be an alternative to surgery in patients with chronic anal fissures. The duration of symptoms should be considered during the evaluation of treatment options.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: Anrecta, Behavioral: sitz bath, Dietary Supplement: nutrition regulationThe control patients self-administered topical glyceryl trinitrate, in the perianal area twice a day (Anrecta, Consentis Pharmaceuticals, Istanbul, Turkey) |
| PRP group | Experimental | Biological: prp injection, Drug: Anrecta, Behavioral: sitz bath, Dietary Supplement: nutrition regulationPRP was injected locally in the anal fissure area and glyceryl trinitrate was administered twice daily in the perianal region as in the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- between 18 and 65 years of age with painful defecation of at least 2 months duration and diagnosed with anal fissure between January and October 2019 were included.
- The diagnosis of chronic anal fissure required :
- the presence of internal sphincter muscle fibers in the base of the fissure
- hypertrophic anal papillae on digital rectal examination
Key exclusion criteria (13 listed)
- Patients with physical examination findings that did not meet the definition of chronic anal fissure
- with painful defecation for less than 2 months,
- atypical fissure location or multiple anal fissures away from the midline
- inflammatory bowel disease
- cancer
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 |
|---|---|---|
| prp injectionAlso: Platelet rich plasma injectionPRP was injected locally in the anal fissure area and glyceryl trinitrate was administered twice daily in the perianal region as in the control group. | Biological | PRP group |
| AnrectaAlso: rectodermself-administered topical glyceryl trinitrate (anrecta), in the perianal area twice a day | Drug | PRP group, control group |
| sitz bathparticipants were told to take a hot water sitz bath once a day | Behavioural | PRP group, control group |
| nutrition regulationThe study participants were told to eat a fiber-rich diet and to drink least 2 liters of water daily | Dietary supplement | PRP group, control group |
Primary outcome
effects of PRP treatment on epithelization .
Time frame: 10 days , 1 month and 2 months
In a clean surgical wound, the epithelial cells migrate downward to meet deep in the dermis. Migration ceases when the layer is rejuvenated. Following surgery, this process is normally complete within 48 hours. However, the process of epithelialization is difficult in wounds that are not primarily closed or need to heal by secondary intention. In these wounds, the physical distance of epithelial migration is changed across the length, width, and depth of the wound. In chronic anal fissures, wound epithelization can be evaluated by inspection. Approximately 80 percent of the original strength of the tissue is obtained within six weeks. So we planned to make this assessment on the 10th Day, 1st Month, and 2nd Month for the reason I explained above. We considered the complete epithelization of the fissure as a complete healing. We evaluated patients with epithelialization in the midline but incomplete as partial epithelization.
effect of PRP treatment on VAS scores
Time frame: 10 days , 1 month and 2 months
Distribution of the effect of PRP treatment on VAS scores. The VAS is a simple scale with a length of 100 mm on which patients were asked to rate their pain from 0 (absence of pain) to 100 (worst pain imaginable). In connection with wound healing, we expect the pain to change. The process of epithelialization is difficult in wounds that are not primarily closed or need to heal by secondary intention. In these wounds, the physical distance of epithelial migration is changed across the length, width, and depth of the wound. So we planned to make this assessment on the 10th Day to evaluate early pain control. we planned In the first month, to evaluate the middle period pain control and in the second month to evaluate the late period pain control.
2 secondary outcomes
effect of PRP treatment on symptoms
Time frame: 10 days , 1 month and 2 months
Comparison of the effect of treatments on pain according to the onset of symptoms of patients
Time frame: 10 days , 1 month and 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Background: PubMed 21538013Altomare DF, Binda GA, Canuti S, Landolfi V, Trompetto M, Villani RD. The management of patients with primary chronic anal fissure: a position paper. Tech Coloproctol. 2011 Jun;15(2):135-41. doi: 10.1007/s10151-011-0683-7. Epub 2011 May 3.
- Background: PubMed 18792671Gupta PJ. Closed anal sphincter manipulation technique for chronic anal fissure. Rev Gastroenterol Mex. 2008 Jan-Mar;73(1):29-32.
- Background: PubMed 22336789Nelson RL, Thomas K, Morgan J, Jones A. Non surgical therapy for anal fissure. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD003431. doi: 10.1002/14651858.CD003431.pub3.
- Background: PubMed 18658016Medhi B, Rao RS, Prakash A, Prakash O, Kaman L, Pandhi P. Recent advances in the pharmacotherapy of chronic anal fissure: an update. Asian J Surg. 2008 Jul;31(3):154-63. doi: 10.1016/S1015-9584(08)60078-0.
- Background: PubMed 27788903Wu PI, Diaz R, Borg-Stein J. Platelet-Rich Plasma. Phys Med Rehabil Clin N Am. 2016 Nov;27(4):825-853. doi: 10.1016/j.pmr.2016.06.002.
- Background: PubMed 22894643Dhillon RS, Schwarz EM, Maloney MD. Platelet-rich plasma therapy - future or trend? Arthritis Res Ther. 2012 Aug 8;14(4):219. doi: 10.1186/ar3914.
- Background: PubMed 31658550Li F, Li Q, Wang LF. [Advances in the research of effects of mesenchymal stem cells, exosomes, and platelet-rich plasma in wound repair]. Zhonghua Shao Shang Za Zhi. 2019 Oct 20;35(10):764-768. doi: 10.3760/cma.j.issn.1009-2587.2019.10.012. Chinese.
- Background: PubMed 29367608Etulain J, Mena HA, Meiss RP, Frechtel G, Gutt S, Negrotto S, Schattner M. An optimised protocol for platelet-rich plasma preparation to improve its angiogenic and regenerative properties. Sci Rep. 2018 Jan 24;8(1):1513. doi: 10.1038/s41598-018-19419-6.
- Background: PubMed 890253Hancock BD. The internal sphincter and anal fissure. Br J Surg. 1977 Feb;64(2):92-5. doi: 10.1002/bjs.1800640204.
- Background: PubMed 13819766EISENHAMMER S. The evaluation of the internal anal sphincterotomy operation with special reference to anal fissure. Surg Gynecol Obstet. 1959 Nov;109:583-90. No abstract available.
- Background: PubMed 5803521Notaras MJ. Lateral subcutaneous sphincterotomy for anal fissure--a new technique. Proc R Soc Med. 1969 Jul 7;62(7):713. doi: 10.1177/003591576906200737. No abstract available.
- Background: PubMed 15906136Casillas S, Hull TL, Zutshi M, Trzcinski R, Bast JF, Xu M. Incontinence after a lateral internal sphincterotomy: are we underestimating it? Dis Colon Rectum. 2005 Jun;48(6):1193-9. doi: 10.1007/s10350-004-0914-3.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing prp injection, Anrecta and sitz bath in people with Anal Fissure Chronic and PRP, run by KTO Karatay 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 7 Apr 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
effects of PRP treatment on epithelization . (time frame: 10 days , 1 month and 2 months). 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 NCT04320498, which also lists 28 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 7 Apr 2022.