Diabetic WoundsNCT06867328
Comparison of Platelet-Rich Plasma Dressing and Normal Saline Dressing for Wound Healing in Patients With Chronic Diabetic Wounds
A study testing Platelet-Rich Plasma (PRP) Dressing and Normal Saline Dressing in people with Diabetic Wounds and Diabetic Ulcers, run by Gulab Devi Hospital at 1 site in Pakistan.
Trial summary
Chronic diabetic wounds are a major health concern, often taking a long time to heal and increasing the risk of complications like infections and amputations. This study aims to compare the effectiveness of Platelet-Rich Plasma (PRP) Dressing versus Normal Saline Dressing in the treatment of chronic diabetic wounds. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetic Wounds, Diabetic Ulcers
- What is being tested?
- Platelet-Rich Plasma (PRP) Dressing and Normal Saline Dressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Nov 2024to 10 May 2025
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years.
- Either male or female.
- Chronic diabetic wound.
- Wagner class III and IV.
Who cannot join
- Wound sustained < 6 weeks from time of presentation.
- Previous history of PRP dressing use, assessed by reviewing previous medical records.
- History of hypersensitivity to PRP, assessed by reviewing previous medical records.
- Burn injury, assessed by reviewing previous medical records.
- Class I, II and V.
Trial locations and contacts
1 site in 1 country.
About this study
Chronic diabetic wounds are a major health concern, often taking a long time to heal and increasing the risk of complications like infections and amputations. This study aims to compare the effectiveness of Platelet-Rich Plasma (PRP) Dressing versus Normal Saline Dressing in the treatment of chronic diabetic wounds. PRP is a treatment derived from the patient's own blood that contains growth factors, which may accelerate wound healing.
Participants with chronic diabetic wounds will be randomly assigned to receive either PRP dressing or normal saline dressing. The study will measure the rate of wound healing and the time taken to achieve complete healing in both groups. It is hypothesized that PRP dressing will lead to faster and more effective wound healing compared to normal saline dressing.
Findings from this research could help improve wound care strategies for diabetic patients and provide evidence for a more effective treatment approach in clinical practice.
Read the detailed description
After obtaining approval from the institutional review board and obtaining informed consent from study participants, all patients fulfilling the inclusion criteria were included in the study from the surgery indoor department of Gulab Devi Hospital, Lahore. Baseline characteristics, including age (in years), gender (male/female), and history of comorbidities (hypertension/ischemic heart disease/smoking), were assessed by reviewing previous medical records and taking a detailed history. The duration of diabetes (in years), duration of the wound (weeks), size of the wound (measured using a millimeter scale along the longest axis), and class of chronic diabetic wound (III/IV) were documented.
After wound debridement, patients were randomized into two equal groups by block randomization as follows:
Group A: Patients were managed with normal saline dressing. Group B: Patients were managed with PRP dressing. In this technique, the wound was washed with normal saline, and platelet-rich plasma (prepared from the patient's own blood by the hematology department) was injected into the surrounding wound area twice weekly, followed by the placement of a gauze over it.
Dressing was continued for a period of 6 weeks or until wound healing was achieved, whichever was shorter. To assess healing, all patients in both groups were followed up weekly until 6 weeks (study endpoint). The duration required to achieve wound healing was also documented. Additionally, 6 weeks post-therapy, wound size was reassessed. In cases of non-healing, alternative therapy was provided based on the wound condition and the consultant surgeon's advice. All data were recorded in a predesigned proforma and kept confidential.
- Conditions
- Diabetic Wounds, Diabetic Ulcers
- Being tested
- Platelet-Rich Plasma (PRP) Dressing, Normal Saline Dressing
- Keywords
- Platelet-Rich Plasma (PRP), Normal Saline Dressing, Diabetic Ulcers, Chronic Wounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Plasma (PRP) DressingProcedure or surgery
- PRP will be prepared by centrifugation of 20 mL venous blood with an anticoagulant.
- The extracted PRP will be applied twice weekly to the wound.
- A sterile gauze will be placed over the wound after PRP application.
- Treatment will continue for up to 6 weeks or until wound healing is achieved.
Normal Saline DressingProcedure or surgery
Wound will be cleansed with normal saline and covered with sterile gauze.
- Dressing changes will be done twice weekly following wound debridement.
- Treatment will continue for up to 6 weeks or until wound healing is achieved.
| Study group | Role | What they receive |
|---|---|---|
| Group PRP Dressing | Experimental | Patients in this group will receive platelet-rich plasma (PRP) dressing, which involves the application of autologous PRP to the chronic diabetic wound site. PRP will be prepared from the patient's own blood and applied twice weekly after wound debridement. Receives: Procedure: Platelet-Rich Plasma (PRP) Dressing |
| Group Normal Saline Dressing | Active comparator | Patients in this group will receive normal saline dressing, which consists of cleansing the wound with normal saline followed by application of sterile gauze. This will be performed twice weekly after wound debridement. Receives: Procedure: Normal Saline Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
Wound healing will be assessed based on the formation of pinkish granulation tissue completely covering the wound. The healing status will be determined by a consultant surgeon through visual inspection.
Measured: Evaluated weekly for up to 6 weeks
Secondary outcomes (1)
Duration to Achieve Wound Healing
The duration required for complete wound healing (formation of granulation tissue covering the entire wound) will be recorded in weeks for each patient in both groups.
Measured: Measured at the end of 6 weeks or at the point of complete wound healing, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start10 Nov 2024
- Primary completion10 May 2025
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic WoundsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulab Devi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adeel Ahmed, Gulab Devi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867328
- Sponsor's protocol ID
- GulabDeviH
- Status last verified
- May 2025
- First submitted
- 4 Mar 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Platelet-Rich Plasma Dressing and Normal Saline Dressing for Wound Healing in Patients With Chronic Diabetic Wounds
- ClinicalTrials.gov ID
- NCT06867328
- Acronym / sponsor ID
- GulabDeviH
- Conditions
- Diabetic Wounds, Diabetic Ulcers
- Keywords
- Platelet-Rich Plasma (PRP), Normal Saline Dressing, Diabetic Ulcers, Chronic Wounds
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Gulab Devi HospitalUniversity, hospital or other
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 10 Mar 2025 (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 diabetic wounds are a major health concern, often taking a long time to heal and increasing the risk of complications like infections and amputations. This study aims to compare the effectiveness of Platelet-Rich Plasma (PRP) Dressing versus Normal Saline Dressing in the treatment of chronic diabetic wounds. PRP is a treatment derived from the patient's own blood that contains growth factors, which may accelerate wound healing.
Participants with chronic diabetic wounds will be randomly assigned to receive either PRP dressing or normal saline dressing. The study will measure the rate of wound healing and the time taken to achieve complete healing in both groups. It is hypothesized that PRP dressing will lead to faster and more effective wound healing compared to normal saline dressing.
Findings from this research could help improve wound care strategies for diabetic patients and provide evidence for a more effective treatment approach in clinical practice.
Detailed description
After obtaining approval from the institutional review board and obtaining informed consent from study participants, all patients fulfilling the inclusion criteria were included in the study from the surgery indoor department of Gulab Devi Hospital, Lahore. Baseline characteristics, including age (in years), gender (male/female), and history of comorbidities (hypertension/ischemic heart disease/smoking), were assessed by reviewing previous medical records and taking a detailed history. The duration of diabetes (in years), duration of the wound (weeks), size of the wound (measured using a millimeter scale along the longest axis), and class of chronic diabetic wound (III/IV) were documented.
After wound debridement, patients were randomized into two equal groups by block randomization as follows:
Group A: Patients were managed with normal saline dressing. Group B: Patients were managed with PRP dressing. In this technique, the wound was washed with normal saline, and platelet-rich plasma (prepared from the patient's own blood by the hematology department) was injected into the surrounding wound area twice weekly, followed by the placement of a gauze over it.
Dressing was continued for a period of 6 weeks or until wound healing was achieved, whichever was shorter. To assess healing, all patients in both groups were followed up weekly until 6 weeks (study endpoint). The duration required to achieve wound healing was also documented. Additionally, 6 weeks post-therapy, wound size was reassessed. In cases of non-healing, alternative therapy was provided based on the wound condition and the consultant surgeon's advice. All data were recorded in a predesigned proforma and kept confidential.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group PRP Dressing | Experimental | Procedure: Platelet-Rich Plasma (PRP) DressingPatients in this group will receive platelet-rich plasma (PRP) dressing, which involves the application of autologous PRP to the chronic diabetic wound site. PRP will be prepared from the patient's own blood and applied twice weekly after wound debridement. |
| Group Normal Saline Dressing | Active comparator | Procedure: Normal Saline DressingPatients in this group will receive normal saline dressing, which consists of cleansing the wound with normal saline followed by application of sterile gauze. This will be performed twice weekly after wound debridement. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-60 years.
- Either male or female.
- Chronic diabetic wound.
- Wagner class III and IV.
Key exclusion criteria (5 listed)
- Wound sustained < 6 weeks from time of presentation.
- Previous history of PRP dressing use, assessed by reviewing previous medical records.
- History of hypersensitivity to PRP, assessed by reviewing previous medical records.
- Burn injury, assessed by reviewing previous medical records.
- Class I, II and V.
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 |
|---|---|---|
| Platelet-Rich Plasma (PRP) Dressing* PRP will be prepared by centrifugation of 20 mL venous blood with an anticoagulant. * The extracted PRP will be applied twice weekly to the wound. * A sterile gauze will be placed over the wound after PRP application. * Treatment will continue for up to 6 weeks or until wound healing is achieved. | Procedure or surgery | Group PRP Dressing |
| Normal Saline DressingWound will be cleansed with normal saline and covered with sterile gauze. * Dressing changes will be done twice weekly following wound debridement. * Treatment will continue for up to 6 weeks or until wound healing is achieved. | Procedure or surgery | Group Normal Saline Dressing |
Primary outcome
Wound Healing
Time frame: Evaluated weekly for up to 6 weeks
Wound healing will be assessed based on the formation of pinkish granulation tissue completely covering the wound. The healing status will be determined by a consultant surgeon through visual inspection.
1 secondary outcome
Duration to Achieve Wound Healing
Time frame: Measured at the end of 6 weeks or at the point of complete wound healing, whichever occurs first.
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 31 May 2025.
- 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 study testing Platelet-Rich Plasma (PRP) Dressing and Normal Saline Dressing in people with Diabetic Wounds and Diabetic Ulcers, run by Gulab Devi Hospital 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 4 inclusion and 5 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 31 May 2025. 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: Evaluated weekly for up to 6 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 31 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.