Diabetic Foot UlcerAPRPNCT03716141
Autologous Platelets Rich Plasma (APRP) Treatment Vs Saline Dressing for the Management of Diabetic Foot Ulcer
A study testing Autologous Platelets Rich Plasma Treatment and Conventional Saline dressing in people with Diabetic Foot Ulcer, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial summary
The aim of this study is to compare between the platelet rich plasma and normal saline dressing in the healing diabetic foot ulcers. It will be a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Autologous Platelets Rich Plasma Treatment and Conventional Saline dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2018to 30 Aug 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic foot wound less than 5cm in greatest diameter Non healing duration greater than 3 months Non infected Palpable distal pulses
Who cannot join
- Infected wound Wound greater than 5 cm Patient having HBa1c greater than 8% Renal failure Wound with bone exposed or having osteomyelitis
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare between the platelet rich plasma and normal saline dressing in the healing diabetic foot ulcers. It will be a randomized controlled trial.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Autologous Platelets Rich Plasma Treatment, Conventional Saline dressing
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelets Rich Plasma TreatmentOther
For PRP preparation 10 mL of the patient blood was collected. The blood was centrifuged at 2000 rpm for 5 min to obtain plasma. Then, this plasma was centrifuged at 3000 rpm for another 5 min to collect platelets. Platelets were diluted in 5 mL plasma to form PRP.
Conventional Saline dressingOther
saline dressing of diabetic wounds will be done
| Study group | Role | What they receive |
|---|---|---|
| Autologous Platelets Rich Plasma | Active comparator | In this group we will be managing diabetic wounds with platelet rich plasma treatment. Receives: Other: Autologous Platelets Rich Plasma Treatment |
| Conventional Saline dressing | Active comparator | In this group we will be managing diabetic wounds with normal saline dressing. Receives: Other: Conventional Saline dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
complete healing of diabetic foot
Measured: 8 to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Jan 2018
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. SamiUllah, Services Hospital, Lahore
- Investigators
- Mahmmood Ayyaz, mbbs, fcps, Study director, Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716141
- Sponsor's protocol ID
- s6
- Acronym
- APRP
- Status last verified
- Oct 2018
- First submitted
- 11 Jul 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Platelets Rich Plasma (APRP) Treatment Vs Saline Dressing for the Management of Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT03716141
- Acronym / sponsor ID
- APRP / s6
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 23 Oct 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.
The aim of this study is to compare between the platelet rich plasma and normal saline dressing in the healing diabetic foot ulcers. It will be a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Platelets Rich Plasma | Active comparator | Other: Autologous Platelets Rich Plasma TreatmentIn this group we will be managing diabetic wounds with platelet rich plasma treatment. |
| Conventional Saline dressing | Active comparator | Other: Conventional Saline dressingIn this group we will be managing diabetic wounds with normal saline dressing. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic foot wound less than 5cm in greatest diameter Non healing duration greater than 3 months Non infected Palpable distal pulses
Key exclusion criteria (1 listed)
- Infected wound Wound greater than 5 cm Patient having HBa1c greater than 8% Renal failure Wound with bone exposed or having osteomyelitis
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 |
|---|---|---|
| Autologous Platelets Rich Plasma TreatmentFor PRP preparation 10 mL of the patient blood was collected. The blood was centrifuged at 2000 rpm for 5 min to obtain plasma. Then, this plasma was centrifuged at 3000 rpm for another 5 min to collect platelets. Platelets were diluted in 5 mL plasma to form PRP. | Other | Autologous Platelets Rich Plasma |
| Conventional Saline dressingsaline dressing of diabetic wounds will be done | Other | Conventional Saline dressing |
Primary outcome
Wound Healing
Time frame: 8 to 12 weeks
complete healing of diabetic foot
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 23 Oct 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Mahmmood Ayyaz, mbbs, fcps study director
Services Hospital, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Platelets Rich Plasma Treatment and Conventional Saline dressing in people with Diabetic Foot Ulcer, run by Services Hospital, Lahore at 1 site in Pakistan.
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 1 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 23 Oct 2018. 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 Pakistan. 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?
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?
Wound Healing (time frame: 8 to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2018.