Chronic Venous Hypertension With Ulcer and InflammationNCT03526913
Role of Platelet Rich Plasma in Enhancing Graft Take in Chronic Venous Ulcers
A study testing PRP and STSG in people with Chronic Venous Hypertension With Ulcer and Inflammation and Chronic Ulcer of Leg or Foot, run by Noha Mohsen Omar.
Trial summary
Chronic venous ulcers are considered a problem with a big morbidity impact on both the health facilities and patients, skin-grafting have shown not so perfect outcomes with such ulcers. Read more about this study
- Who is it for?
- Ages 12 years and older, men only
- Conditions the study is for
- Chronic Venous Hypertension With Ulcer and Inflammation, Chronic Ulcer of Leg or Foot
- What is being tested?
- PRP and STSG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 1 Feb 2018
- 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 12 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with chronic ulcers for at least 6 months.
- Age ≧ 12 years.
Who cannot join
- Patients younger than 12 years of age.
- Patients with diabetes or other diseases affecting tissue healing.
- Patients with current ongoing pathologies in arterial or venous systems.
- Patients with malignant ulcers.
- Patients on corticosteroids or other drugs affecting tissue healing.
- Patients with unrealistic expectations.
About this study
Chronic venous ulcers are considered a problem with a big morbidity impact on both the health facilities and patients, skin-grafting have shown not so perfect outcomes with such ulcers. In this study, the investigators compare combining autologous platelet rich plasma treatments with partial skin grafting in chronic ulcers, the results were compared to using only partial skin grafting, and among various types of chronic resistant ulcers.
Read the detailed description
Fourteen patients had bilateral lower limb ulcers, and 6 of them had single large ulcers as follows; Fourteen patients with chronic venous ulcers (12 of which had bilateral ulcers, 2 had single large ulcers) Four patients, each with a single chronic post-traumatic ulcer Two patients with bilateral chronic lymphatic ulcers.
After detailed history, physical examination and investigations (such as duplex),
- Each patient with bilateral ulcers included in the study (14 patients) received treatment A on one ulcer and treatment B on the other ulcer.
- In case of patients with single large ulcers (6 patients), treatment A was done on one half of the ulcer and treatment B on the other half of the ulcer (done in ulcers with an area greater than 10 x 10 cms).
- Treatment A included pre-operative intra-lesional PRP injections in 1-week intervals for 3 times, followed by intra-operative intra-lesional injection of PRP prior to meshed graft placement. PRP was injected into the ulcer bed and ulcer edges using a sterile syringe.
Treatment B included only placement of meshed graft, with no PRP treatment.
- Pre-operative preparation: Ulcers were prepared by proper dressings and followed up until acquiring a clean bed. Debridement was done as needed to obtain clean base ready for graft placement.
- PRP preparation:
- 10 ml of blood was drawn from each patient intra operatively (autologous PRP).
- Blood was collected in sterile tubes, Anticoagulant Citrate Dextrose (ACD) was used for anticoagulation, which is the same substance used to preserve viable platelets in blood banks for platelet transfer.
- Tubes were centrifuged in Beckman Allerga X-12 centrifuge for 20 mins, 3000 rpm.
- Each 10 ml of blood yielded an average of 3-4 ml of PRP. Calcium gluconate was added in a ratio of 1:10 to PRP. Post-operative assessment was carried out by follow up clinical examination, photography and weekly biopsy samples.
- Being tested
- PRP, STSG
- Keywords
- chronic leg ulcers, PRP, split-thickness skin graft, platelet-rich plasma
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPProcedure or surgery
Also called platelet rich plasma
PRP: autologous platelet-rich plasma
STSGProcedure or surgery
Also called split thickness skin graft
skin graft: Split Thickness Skin Grafting (STSG)
| Study group | Role | What they receive |
|---|---|---|
| PRP + STSG | Experimental | autologous PRP treatments every week prior to graft placement (STSG) Receives: Procedure: PRP; Procedure: STSG |
| STSG Split Thickness Skin Graft | Active comparator | skin graft (STSG) (intervention) Receives: Procedure: STSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft take
percentage of graft take
Measured: month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start1 Feb 2016
- Primary completion1 Sep 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous Hypertension With Ulcer and InflammationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Comparison of combined autologous PRP and skin grafting to skin grafting alone in chronic leg ulcers (comparing one ulcer to another in bilateral cases, or one half of ulcer to the other in big ulcers)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noha Mohsen Omar
- Sponsor type
- University, hospital or other
- Collaborators
- Menoufia University
- Responsible party
- Sponsor-investigator, Noha Mohsen Omar, Menoufia University
- Investigators
- Sherif M. Elkashty, PHD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526913
- Sponsor's protocol ID
- 1
- Status last verified
- May 2018
- First submitted
- 4 May 2018
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Comparison of combined pre and intra-operative PRP treatments with STSG to only STSG in treatment of chronic ulcers with special emphasis on venous ulcers.
Publications
Fonder MA, Lazarus GS, Cowan DA, Aronson-Cook B, Kohli AR, Mamelak AJ. Treating the chronic wound: A practical approach to the care of nonhealing wounds and wound care dressings. J Am Acad Dermatol. 2008 Feb;58(2):185-206. doi: 10.1016/j.jaad.2007.08.048.
PubMed 18222318Raffetto JD, Khalil RA. Matrix metalloproteinases and their inhibitors in vascular remodeling and vascular disease. Biochem Pharmacol. 2008 Jan 15;75(2):346-59. doi: 10.1016/j.bcp.2007.07.004. Epub 2007 Jul 7.
PubMed 17678629Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev. 2003 Jul;83(3):835-70. doi: 10.1152/physrev.2003.83.3.835.
PubMed 12843410Eppley BL, Woodell JE, Higgins J. Platelet quantification and growth factor analysis from platelet-rich plasma: implications for wound healing. Plast Reconstr Surg. 2004 Nov;114(6):1502-8. doi: 10.1097/01.prs.0000138251.07040.51.
PubMed 15509939Pietramaggiori G, Scherer SS, Mathews JC, Gennaoui T, Lancerotto L, Ragno G, Valeri CR, Orgill DP. Quiescent platelets stimulate angiogenesis and diabetic wound repair. J Surg Res. 2010 May 1;160(1):169-77. doi: 10.1016/j.jss.2008.09.010. Epub 2008 Oct 10.
PubMed 19482315Kakudo N, Minakata T, Mitsui T, Kushida S, Notodihardjo FZ, Kusumoto K. Proliferation-promoting effect of platelet-rich plasma on human adipose-derived stem cells and human dermal fibroblasts. Plast Reconstr Surg. 2008 Nov;122(5):1352-1360. doi: 10.1097/PRS.0b013e3181882046.
PubMed 18971718Schultz GS, Sibbald RG, Falanga V, Ayello EA, Dowsett C, Harding K, Romanelli M, Stacey MC, Teot L, Vanscheidt W. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003 Mar;11 Suppl 1:S1-28. doi: 10.1046/j.1524-475x.11.s2.1.x.
PubMed 12654015Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):560-582. doi: 10.1089/wound.2015.0635.
PubMed 26339534Knighton DR, Ciresi K, Fiegel VD, Schumerth S, Butler E, Cerra F. Stimulation of repair in chronic, nonhealing, cutaneous ulcers using platelet-derived wound healing formula. Surg Gynecol Obstet. 1990 Jan;170(1):56-60.
PubMed 2403699
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Platelet Rich Plasma in Enhancing Graft Take in Chronic Venous Ulcers
- ClinicalTrials.gov ID
- NCT03526913
- Acronym / sponsor ID
- 1
- Keywords
- chronic leg ulcers, PRP, split-thickness skin graft, platelet-rich plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Noha Mohsen OmarUniversity, hospital or other
- Collaborators
- Menoufia University
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 16 May 2018 (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.
Chronic venous ulcers are considered a problem with a big morbidity impact on both the health facilities and patients, skin-grafting have shown not so perfect outcomes with such ulcers. In this study, the investigators compare combining autologous platelet rich plasma treatments with partial skin grafting in chronic ulcers, the results were compared to using only partial skin grafting, and among various types of chronic resistant ulcers.
Detailed description
Fourteen patients had bilateral lower limb ulcers, and 6 of them had single large ulcers as follows; Fourteen patients with chronic venous ulcers (12 of which had bilateral ulcers, 2 had single large ulcers) Four patients, each with a single chronic post-traumatic ulcer Two patients with bilateral chronic lymphatic ulcers.
After detailed history, physical examination and investigations (such as duplex),
- Each patient with bilateral ulcers included in the study (14 patients) received treatment A on one ulcer and treatment B on the other ulcer.
- In case of patients with single large ulcers (6 patients), treatment A was done on one half of the ulcer and treatment B on the other half of the ulcer (done in ulcers with an area greater than 10 x 10 cms).
- Treatment A included pre-operative intra-lesional PRP injections in 1-week intervals for 3 times, followed by intra-operative intra-lesional injection of PRP prior to meshed graft placement. PRP was injected into the ulcer bed and ulcer edges using a sterile syringe.
Treatment B included only placement of meshed graft, with no PRP treatment.
- Pre-operative preparation: Ulcers were prepared by proper dressings and followed up until acquiring a clean bed. Debridement was done as needed to obtain clean base ready for graft placement.
- PRP preparation:
- 10 ml of blood was drawn from each patient intra operatively (autologous PRP).
- Blood was collected in sterile tubes, Anticoagulant Citrate Dextrose (ACD) was used for anticoagulation, which is the same substance used to preserve viable platelets in blood banks for platelet transfer.
- Tubes were centrifuged in Beckman Allerga X-12 centrifuge for 20 mins, 3000 rpm.
- Each 10 ml of blood yielded an average of 3-4 ml of PRP. Calcium gluconate was added in a ratio of 1:10 to PRP. Post-operative assessment was carried out by follow up clinical examination, photography and weekly biopsy samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Comparison of combined autologous PRP and skin grafting to skin grafting alone in chronic leg ulcers (comparing one ulcer to another in bilateral cases, or one half of ulcer to the other in big ulcers)
| Arm | Type | Receives |
|---|---|---|
| PRP + STSG | Experimental | Procedure: PRP, Procedure: STSGautologous PRP treatments every week prior to graft placement (STSG) |
| STSG Split Thickness Skin Graft | Active comparator | Procedure: STSGskin graft (STSG) (intervention) |
Who may qualify
- Ages
- 12 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with chronic ulcers for at least 6 months.
- Age ≧ 12 years.
Key exclusion criteria (6 listed)
- Patients younger than 12 years of age.
- Patients with diabetes or other diseases affecting tissue healing.
- Patients with current ongoing pathologies in arterial or venous systems.
- Patients with malignant ulcers.
- Patients on corticosteroids or other drugs affecting tissue healing.
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 |
|---|---|---|
| PRPAlso: platelet rich plasmaPRP: autologous platelet-rich plasma | Procedure or surgery | PRP + STSG |
| STSGAlso: split thickness skin graftskin graft: Split Thickness Skin Grafting (STSG) | Procedure or surgery | PRP + STSG, STSG Split Thickness Skin Graft |
Primary outcome
Graft take
Time frame: month
percentage of graft take
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 18 May 2018.
- Background: PubMed 18222318Fonder MA, Lazarus GS, Cowan DA, Aronson-Cook B, Kohli AR, Mamelak AJ. Treating the chronic wound: A practical approach to the care of nonhealing wounds and wound care dressings. J Am Acad Dermatol. 2008 Feb;58(2):185-206. doi: 10.1016/j.jaad.2007.08.048.
- Background: PubMed 17678629Raffetto JD, Khalil RA. Matrix metalloproteinases and their inhibitors in vascular remodeling and vascular disease. Biochem Pharmacol. 2008 Jan 15;75(2):346-59. doi: 10.1016/j.bcp.2007.07.004. Epub 2007 Jul 7.
- Background: PubMed 12843410Werner S, Grose R. Regulation of wound healing by growth factors and cytokines. Physiol Rev. 2003 Jul;83(3):835-70. doi: 10.1152/physrev.2003.83.3.835.
- Background: PubMed 15509939Eppley BL, Woodell JE, Higgins J. Platelet quantification and growth factor analysis from platelet-rich plasma: implications for wound healing. Plast Reconstr Surg. 2004 Nov;114(6):1502-8. doi: 10.1097/01.prs.0000138251.07040.51.
- Background: PubMed 19482315Pietramaggiori G, Scherer SS, Mathews JC, Gennaoui T, Lancerotto L, Ragno G, Valeri CR, Orgill DP. Quiescent platelets stimulate angiogenesis and diabetic wound repair. J Surg Res. 2010 May 1;160(1):169-77. doi: 10.1016/j.jss.2008.09.010. Epub 2008 Oct 10.
- Background: PubMed 18971718Kakudo N, Minakata T, Mitsui T, Kushida S, Notodihardjo FZ, Kusumoto K. Proliferation-promoting effect of platelet-rich plasma on human adipose-derived stem cells and human dermal fibroblasts. Plast Reconstr Surg. 2008 Nov;122(5):1352-1360. doi: 10.1097/PRS.0b013e3181882046.
- Background: PubMed 12654015Schultz GS, Sibbald RG, Falanga V, Ayello EA, Dowsett C, Harding K, Romanelli M, Stacey MC, Teot L, Vanscheidt W. Wound bed preparation: a systematic approach to wound management. Wound Repair Regen. 2003 Mar;11 Suppl 1:S1-28. doi: 10.1046/j.1524-475x.11.s2.1.x.
- Background: PubMed 26339534Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):560-582. doi: 10.1089/wound.2015.0635.
- Background: PubMed 2403699Knighton DR, Ciresi K, Fiegel VD, Schumerth S, Butler E, Cerra F. Stimulation of repair in chronic, nonhealing, cutaneous ulcers using platelet-derived wound healing formula. Surg Gynecol Obstet. 1990 Jan;170(1):56-60.
- Individual participant dataSharing planned: Yes. Comparison of combined pre and intra-operative PRP treatments with STSG to only STSG in treatment of chronic ulcers with special emphasis on venous ulcers.
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.
Sherif M. Elkashty, PHD principal investigator
Menoufia University
Questions about this trial
What is this clinical trial studying?
A study testing PRP and STSG in people with Chronic Venous Hypertension With Ulcer and Inflammation and Chronic Ulcer of Leg or Foot, run by Noha Mohsen Omar.
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 2 inclusion and 6 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 18 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Graft take (time frame: month). 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 NCT03526913, which also lists 9 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 18 May 2018.