Platelet Rich PlasmaPhase 2NCT04750837
Platelet Rich Plasma and Diabetic Foot Ulcer
A Phase 2 study testing debridement of the wound, platelet rich plasma and conventional dressing in people with Platelet Rich Plasma, run by Zagazig University at 1 site in Egypt.
Trial summary
In chronic diabetic foot ulcer, if the conventional dressing fails, new therapeutic options such as recombinant human growth factors and bioengineered skin substitutes may be beneficial, but the cost is a limiting factor. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Platelet Rich Plasma
- What is being tested?
- debridement of the wound, platelet rich plasma and conventional dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jan 2020to 20 Jan 2021
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with chronic diabetic foot ulcers more than 1 cm in diameter that failed to heal in three months after wound debridement and dressing by a surgeon.
Who cannot join
- Patients with evident local infection or gangrene (no redness, no hotness, no purulent discharge, no osteomyelitis in X-ray with a negative probe to bone test, and negative C-reactive protein).
- Patients with end-stage organ failure, hepatic, or renal failure.
- Patients on anticoagulants.
- Patients on antiplatelet agents.
- Patients with thrombocytopenia.
- Patients on steroid therapy.
Show all 9Show fewer
- Ulcers less than 1cm or greater than 8 cm in diameter.
- Deep ulcers more than 2 cm in depth.
- Patients with lower limb ischemia (acute or chronic). Limb ischemia was excluded by the detection of the distal limb pulsations with ankle-brachial index>0.9.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Zagazig University Faculty of Human Medicine
Zagazig, Sharqia Province, 44519
About this study
Official title: Autologous Platelet-Rich Plasma Versus Conventional Dressing Method in the Treatment of Chronic Diabetic Foot Ulcers
In chronic diabetic foot ulcer, if the conventional dressing fails, new therapeutic options such as recombinant human growth factors and bioengineered skin substitutes may be beneficial, but the cost is a limiting factor. Autologous platelet rich plasma is a cost-effective method that enhances wound healing by promoting the healing process by local release of growth factors.
Read the detailed description
The term "chronic wound" was first used in literature in the 1950s to refer to wounds that were difficult to heal or did not follow a normal healing process. However, the term has met criticism for its uncertainty regarding the duration of chronicity. Martin \& Nunan, 2015, defined a "chronic wound" as a barrier defect that has not healed in 3 months, and Leaper \& Durani, 2008, defined it as a wound that lacks a 20-40% reduction in its size after 2-4 weeks of optimal treatment or when there is no complete healing after 6 weeks. Recent reviews have highlighted the lack of consensus regarding the definition of a "chronic wound" and the need for further researches in this area.
Diabetic foot ulcer is a major complication of diabetes mellitus and is the major component of diabetic foot syndrome. This medical condition affects 15% of all patients with diabetes mellitus. Alvarsson et al. in 2012 reported that up to 88% of all lower leg amputations were related to diabetic foot ulcers.
The impact of chronic wounds on the health and quality of patients' life and their families should not be underestimated. Patients with chronic wounds may experience chronic pain, loss of function and mobility, depression, and anxiety, increased social stress and isolation, prolonged hospitalization, increased financial burden, and increased morbidity and mortality.
Growth factors (GFs) play an essential role in the process of wound healing and tissue regeneration. Each GF has more than one effect on the healing process and acts by binding to specific cell membrane receptors on the target cells. Growth factors' effects include promoting chemotaxis, inducing cell migration and proliferation, and stimulate cells to upregulate protein production. These growth factors not only regulate cell migration and proliferation but also promote angiogenesis and remodel the extracellular matrix, creating an ideal environment that favors the cutaneous wound healing process.
Over the last decades, the use of emerging cellular therapies, such as platelet-rich plasma (PRP), has more attention in a variety of diseases and settings for its potential use in the regenerative medicine as a therapeutic agent and can have an adjunctive role in a standardized, quality treatment plan.
PRP is defined as plasma containing above-baseline concentrations of platelets, which is from 140 000-400 000/μl. PRP is isolated through the centrifugation of whole blood. Simply, its actions are based on the infusion of elevated platelets, thereby theoretically enhancing the biological healing capacity and tissue generation in the wound bed. Enzyme-linked immunosorbent assay studies of PRP have quantified the presence of increases in GFs such as transforming GF β, epidermal GF, and platelet-derived GF. Through degranulation of the alpha granules in platelets, PRP can secrete various GFs, which have been documented to initiate the wound healing process
- Conditions
- Platelet Rich Plasma
- Being tested
- debridement of the wound, platelet rich plasma, conventional dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
debridement of the woundProcedure or surgery
The edges and the floor of the wound were firstly debrided, and any callosities around the wound were removed. This was repeated if needed when callosities around the wound reappeared. By this technique, the chronic wound was transformed into an acute one
platelet rich plasmaBiological
Part of activated PRP was injected around the wound and under the base of the wound, while another portion of PRP was left over the floor of the wound and let to coagulate and form a gel.
conventional dressingProcedure or surgery
The wound was irrigated by normal saline, covered by vaseline gauze then sterile dressing. Repeated dressing every two days till 20 weeks, if the wound failed to heal at that time
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich plasma group | Active comparator | chronic diabetic foot ulcer was treated by platelet rich plasma Receives: Procedure: debridement of the wound; Biological: platelet rich plasma; Procedure: conventional dressing |
| conventional dressing group | Sham comparator | chronic diabetic foot ulcer was treated by conventional dressing Receives: Procedure: debridement of the wound; Procedure: conventional dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
size of the ulcer reduce to zero cm
complete coverage of the ulcer base by healthy tissue
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start16 Jan 2020
- Primary completion21 Dec 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Platelet Rich PlasmaStudies of the same condition, open and under way.
- More trials run by Zagazig 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups one group managed by conventional dressing and the other by platelet rich plasma
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yasser Ali Orban, Zagazig University
- Investigators
- Yasser A. Orban, Lecturer, Principal investigator, zagazig university faculty of human medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750837
- Sponsor's protocol ID
- Platelet rich plasma
- Status last verified
- Feb 2021
- First submitted
- 7 Feb 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
GREELEY PW. Plastic surgical closure of chronic open wounds of the leg. Ind Med Surg. 1953 Jan;22(1):22-3. No abstract available.
PubMed 13022118CARLESON R, GARSTEN P. [Wound therapy with septofyllin, with special consideration of its effect on chronic leg ulcers]. Nord Med. 1952 Mar 28;47(13):412-6. No abstract available. Undetermined Language.
PubMed 14941406Martin P, Nunan R. Cellular and molecular mechanisms of repair in acute and chronic wound healing. Br J Dermatol. 2015 Aug;173(2):370-8. doi: 10.1111/bjd.13954. Epub 2015 Jul 14.
PubMed 26175283Leaper DJ, Durani P. Topical antimicrobial therapy of chronic wounds healing by secondary intention using iodine products. Int Wound J. 2008 Jun;5(2):361-8. doi: 10.1111/j.1742-481X.2007.00406.x.
PubMed 18494641Gould L, Abadir P, Brem H, Carter M, Conner-Kerr T, Davidson J, DiPietro L, Falanga V, Fife C, Gardner S, Grice E, Harmon J, Hazzard WR, High KP, Houghton P, Jacobson N, Kirsner RS, Kovacs EJ, Margolis D, McFarland Horne F, Reed MJ, Sullivan DH, Thom S, Tomic-Canic M, Walston J, Whitney J, Williams J, Zieman S, Schmader K. Chronic wound repair and healing in older adults: current status and future research. Wound Repair Regen. 2015 Jan-Feb;23(1):1-13. doi: 10.1111/wrr.12245. Epub 2015 Feb 13.
PubMed 25486905Baba M, Davis WA, Norman PE, Davis TM. Temporal changes in the prevalence and associates of foot ulceration in type 2 diabetes: the Fremantle Diabetes Study. J Diabetes Complications. 2015 Apr;29(3):356-61. doi: 10.1016/j.jdiacomp.2015.01.008. Epub 2015 Jan 19.
PubMed 25670409Jarbrink K, Ni G, Sonnergren H, Schmidtchen A, Pang C, Bajpai R, Car J. Prevalence and incidence of chronic wounds and related complications: a protocol for a systematic review. Syst Rev. 2016 Sep 8;5(1):152. doi: 10.1186/s13643-016-0329-y.
PubMed 27609108
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Platelet-Rich Plasma Versus Conventional Dressing Method in the Treatment of Chronic Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT04750837
- Acronym / sponsor ID
- Platelet rich plasma
- Conditions
- Platelet Rich Plasma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 21 Dec 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 11 Feb 2021 (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.
In chronic diabetic foot ulcer, if the conventional dressing fails, new therapeutic options such as recombinant human growth factors and bioengineered skin substitutes may be beneficial, but the cost is a limiting factor. Autologous platelet rich plasma is a cost-effective method that enhances wound healing by promoting the healing process by local release of growth factors.
Detailed description
The term "chronic wound" was first used in literature in the 1950s to refer to wounds that were difficult to heal or did not follow a normal healing process. However, the term has met criticism for its uncertainty regarding the duration of chronicity. Martin \& Nunan, 2015, defined a "chronic wound" as a barrier defect that has not healed in 3 months, and Leaper \& Durani, 2008, defined it as a wound that lacks a 20-40% reduction in its size after 2-4 weeks of optimal treatment or when there is no complete healing after 6 weeks. Recent reviews have highlighted the lack of consensus regarding the definition of a "chronic wound" and the need for further researches in this area.
Diabetic foot ulcer is a major complication of diabetes mellitus and is the major component of diabetic foot syndrome. This medical condition affects 15% of all patients with diabetes mellitus. Alvarsson et al. in 2012 reported that up to 88% of all lower leg amputations were related to diabetic foot ulcers.
The impact of chronic wounds on the health and quality of patients' life and their families should not be underestimated. Patients with chronic wounds may experience chronic pain, loss of function and mobility, depression, and anxiety, increased social stress and isolation, prolonged hospitalization, increased financial burden, and increased morbidity and mortality.
Growth factors (GFs) play an essential role in the process of wound healing and tissue regeneration. Each GF has more than one effect on the healing process and acts by binding to specific cell membrane receptors on the target cells. Growth factors' effects include promoting chemotaxis, inducing cell migration and proliferation, and stimulate cells to upregulate protein production. These growth factors not only regulate cell migration and proliferation but also promote angiogenesis and remodel the extracellular matrix, creating an ideal environment that favors the cutaneous wound healing process.
Over the last decades, the use of emerging cellular therapies, such as platelet-rich plasma (PRP), has more attention in a variety of diseases and settings for its potential use in the regenerative medicine as a therapeutic agent and can have an adjunctive role in a standardized, quality treatment plan.
PRP is defined as plasma containing above-baseline concentrations of platelets, which is from 140 000-400 000/μl. PRP is isolated through the centrifugation of whole blood. Simply, its actions are based on the infusion of elevated platelets, thereby theoretically enhancing the biological healing capacity and tissue generation in the wound bed. Enzyme-linked immunosorbent assay studies of PRP have quantified the presence of increases in GFs such as transforming GF β, epidermal GF, and platelet-derived GF. Through degranulation of the alpha granules in platelets, PRP can secrete various GFs, which have been documented to initiate the wound healing process
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 groups one group managed by conventional dressing and the other by platelet rich plasma
| Arm | Type | Receives |
|---|---|---|
| Platelet rich plasma group | Active comparator | Procedure: debridement of the wound, Biological: platelet rich plasma, Procedure: conventional dressingchronic diabetic foot ulcer was treated by platelet rich plasma |
| conventional dressing group | Sham comparator | Procedure: debridement of the wound, Procedure: conventional dressingchronic diabetic foot ulcer was treated by conventional dressing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic diabetic foot ulcers more than 1 cm in diameter that failed to heal in three months after wound debridement and dressing by a surgeon.
Key exclusion criteria (9 listed)
- Patients with evident local infection or gangrene (no redness, no hotness, no purulent discharge, no osteomyelitis in X-ray with a negative probe to bone test, and negative C-reactive protein).
- Patients with end-stage organ failure, hepatic, or renal failure.
- Patients on anticoagulants.
- Patients on antiplatelet agents.
- Patients with thrombocytopenia.
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 |
|---|---|---|
| debridement of the woundThe edges and the floor of the wound were firstly debrided, and any callosities around the wound were removed. This was repeated if needed when callosities around the wound reappeared. By this technique, the chronic wound was transformed into an acute one | Procedure or surgery | Platelet rich plasma group, conventional dressing group |
| platelet rich plasmaPart of activated PRP was injected around the wound and under the base of the wound, while another portion of PRP was left over the floor of the wound and let to coagulate and form a gel. | Biological | Platelet rich plasma group |
| conventional dressingThe wound was irrigated by normal saline, covered by vaseline gauze then sterile dressing. Repeated dressing every two days till 20 weeks, if the wound failed to heal at that time | Procedure or surgery | Platelet rich plasma group, conventional dressing group |
Primary outcome
size of the ulcer reduce to zero cm
Time frame: 20 weeks
complete coverage of the ulcer base by healthy tissue
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 11 Feb 2021.
- Background: PubMed 13022118GREELEY PW. Plastic surgical closure of chronic open wounds of the leg. Ind Med Surg. 1953 Jan;22(1):22-3. No abstract available.
- Background: PubMed 14941406CARLESON R, GARSTEN P. [Wound therapy with septofyllin, with special consideration of its effect on chronic leg ulcers]. Nord Med. 1952 Mar 28;47(13):412-6. No abstract available. Undetermined Language.
- Background: PubMed 26175283Martin P, Nunan R. Cellular and molecular mechanisms of repair in acute and chronic wound healing. Br J Dermatol. 2015 Aug;173(2):370-8. doi: 10.1111/bjd.13954. Epub 2015 Jul 14.
- Background: PubMed 18494641Leaper DJ, Durani P. Topical antimicrobial therapy of chronic wounds healing by secondary intention using iodine products. Int Wound J. 2008 Jun;5(2):361-8. doi: 10.1111/j.1742-481X.2007.00406.x.
- Background: PubMed 25486905Gould L, Abadir P, Brem H, Carter M, Conner-Kerr T, Davidson J, DiPietro L, Falanga V, Fife C, Gardner S, Grice E, Harmon J, Hazzard WR, High KP, Houghton P, Jacobson N, Kirsner RS, Kovacs EJ, Margolis D, McFarland Horne F, Reed MJ, Sullivan DH, Thom S, Tomic-Canic M, Walston J, Whitney J, Williams J, Zieman S, Schmader K. Chronic wound repair and healing in older adults: current status and future research. Wound Repair Regen. 2015 Jan-Feb;23(1):1-13. doi: 10.1111/wrr.12245. Epub 2015 Feb 13.
- Background: PubMed 25670409Baba M, Davis WA, Norman PE, Davis TM. Temporal changes in the prevalence and associates of foot ulceration in type 2 diabetes: the Fremantle Diabetes Study. J Diabetes Complications. 2015 Apr;29(3):356-61. doi: 10.1016/j.jdiacomp.2015.01.008. Epub 2015 Jan 19.
- Background: PubMed 27609108Jarbrink K, Ni G, Sonnergren H, Schmidtchen A, Pang C, Bajpai R, Car J. Prevalence and incidence of chronic wounds and related complications: a protocol for a systematic review. Syst Rev. 2016 Sep 8;5(1):152. doi: 10.1186/s13643-016-0329-y.
- 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.
Yasser A. Orban, Lecturer principal investigator
zagazig university faculty of human medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing debridement of the wound, platelet rich plasma and conventional dressing in people with Platelet Rich Plasma, run by Zagazig University at 1 site in Egypt.
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 1 inclusion and 9 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 11 Feb 2021. 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 Egypt. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
size of the ulcer reduce to zero cm (time frame: 20 weeks). 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 NCT04750837, which also lists 7 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 11 Feb 2021.