Diabetic Foot UlcerPhase 2NCT05671250

Bioactive Smart Dressings for Diabetic Foot Ulcers: Randomized Controlled Trial

A Phase 2 study testing PRP gel and SOC-treatment and EPO/ISDN/UFH cryogel dressing in people with Diabetic Foot Ulcer, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

We propose a randomized controlled study to assess the efficacy of: 1. Platelet-lysate loaded sustained release thermo-gelling formulation (Platelets-SR) 2. EPO/ISDN/UFH cryogel dressing (Trigel) As adjuncts to standard-of-care (SOC) in the treatment of chronic DFUs compared to SOC alone for patients attending the DFU… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Foot Ulcer
What is being tested?: PRP gel and SOC-treatment and EPO/ISDN/UFH cryogel dressing
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteEgypt
Study dates: 15 Jul 2021to 1 Jan 2023
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female age of ≥ 18
Type 2 Diabetes Mellitus diagnosed as per the American Diabetic Association at the time of recruitment
Patients with glycated haemoglobin (HbA1C) ≤ 9% within 4 weeks prior to randomization
Patients with ulcer that meets the following criteria
Ulcers classified as Grade 1, stage A (1A) ulcers using University of Texas (UT) classification system (ulcers are superficial not involving tendon, capsule or tendon and are non-infected and non-ischemic)
Ulcer duration of 4 weeks or longer and hard to heal despite standard of care treatment (chronic ulcers)

Show all 13Show fewer

Ulcer has undergone recent debridement (2 weeks prior to screening)
Post-debridement ulcer is free of necrotic debris, foreign bodies, sinus tracts, tunnelling, and undermining and is comprised of healthy vascularized tissue
Wound area at start of treatment between 2 sq.cm. and 10 sq.cm.
No surgical revascularization of the limb with the DFU was done in the previous two months.
Limb criteria: At least moderate blood perfusion into the affected limb as defined by Ankle Brachial Index (ABI) of 0.9 - 1.3.
Patients who agree to conform to the off-loading requirements
Provide written informed consent prior to admission into the study

Who cannot join

Type 1 Diabetes Mellitus
Patients who have undergone, in the 2-week period prior to enrolment, treatment for DFU with any advanced treatment modality other than standard of care, such as growth factors, skin substitutes or other biological treatments
Have a glycosylated haemoglobin (HbA1c) > 9.0%
Have a body mass index (BMI) > 40 Kg/m2
Have a clinically significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease
Anaemia (Haemoglobin < 9 g/dL) or white Blood Cells count > 11,000/μL or platelets count < 100,000/μL or > 400,000/μL or liver function tests > 3 times upper normal lab values or Creatinine > 3 mg/dL; any indication of malnourishment (Albumin < 3 g/dL); INR > 2 or any other clinically significant blood and urinalysis tests per the physician's discretion

Show all 14Show fewer

Patients with haemochromatosis or unstable hypertension
Have any clinically significant chronic or acute illness during the 4 weeks prior to admission into the study, except type 2 diabetes or during screening period
Patients with wounds caused by basal cell carcinoma or due to basal cell carcinoma excision
Females who are pregnant, lactating, of child-bearing potential, or post-menopausal for less than 2 years, not using a medically approved method of contraception, or females who test positive on a blood-based pregnancy test.
Patients with a history of allergy to one of tested components
Patients on glyceryl trinitrate or Sildenafil treatment
Patients with a history of any clinical or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational agent or may confound the interpretation of study results or might render the patient at high risk for treatment complications
Patients with active Charcot or other structural deformity that would prevent adequate off-loading of the study foot.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Toaa Ashraf
Al Mansurah, 35516

Other trials in Egypt

About this study

Official title: Novel Bioactive Smart Dressings for Diabetic Foot Ulcers: a Randomized Controlled Trial Comparing Efficacy of PRP-loaded Lyophilized Gel vs. Erythropoietin/Isosorbide Dinitrate Cryogel Scaffold vs. Standard of Care

We propose a randomized controlled study to assess the efficacy of:

Platelet-lysate loaded sustained release thermo-gelling formulation (Platelets-SR)
EPO/ISDN/UFH cryogel dressing (Trigel) As adjuncts to standard-of-care (SOC) in the treatment of chronic DFUs compared to SOC alone for patients attending the DFU outpatient clinic at the Gastroenterology Centre, Mansoura University.

Read the detailed description

The tested treatments were manufactured, tested and optimized in the research laboratories of Pharmacy School, Mansoura University under ethical approval of Pharmacy School ethics committee and Medical School IRB committee.

Our primary objective is to test the hypothesis that the proposed treatments can significantly improve the wound area regression rate assessed weekly (cm2/week) for 8 weeks as compared to SOC treatment alone.

Our secondary objectives are to assess the following: the time to complete wound closure, the rate of complete wound closure and the rate of partial wound closure of ≥ 50% and ≥ 75% at end-of-treatment visit (week 8). Wound closure is confirmed when the wound remains closed at two follow up visits. The occurrence of any adverse effects either locally or systemically will be surveilled in order to assess the safety profile of the test formulations.

Conditions: Diabetic Foot Ulcer
Being tested: PRP gel and SOC-treatment, EPO/ISDN/UFH cryogel dressing, Standard of Care
Medical subject headings: Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PRP gel and SOC-treatmentCombination product
Platelet-lysate loaded sustained release thermo-gelling formulation
EPO/ISDN/UFH cryogel dressingCombination product
Erythropoietin/Isosorbide dinitrate loaded cryogel scaffold
Standard of CareProcedure or surgery
Sharp debridement, saline washing and regular saline dressing

Study groups in NCT05671250
Study group	Role	What they receive
PRP gel and SOC-treatment	Experimental	platelet-lysate loaded lyophilized gel in addition to standard of care Receives: Combination Product: PRP gel and SOC-treatment
Trigel and SOC-treatment	Experimental	Erythropoietin/isosorbide dinitrate loaded cryogel scaffold in addition to standard of care Receives: Combination Product: EPO/ISDN/UFH cryogel dressing
standard of care alone	Active comparator	sharp debridement, saline washing and saline dressing Receives: Procedure: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Wound area regression rate
wound area regression rate assessed weekly (cm2/week)
Measured: 8 weeks

Secondary outcomes (3)

rate of complete wound closure
rate of complete wound closure (100% closure)
Measured: 8 weeks
rate of partial wound closure of ≥ 75%
rate of partial wound closure of ≥ 75%
Measured: 8 weeks
rate of partial wound closure of ≥ 50%
rate of partial wound closure of ≥ 50%
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 20211 Jan 2023

First posted4 Jan 2023
Study start15 Jul 2021
Primary completion1 Nov 2022
Study completion1 Jan 2023

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.
More trials run by Mansoura 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
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05671250
Sponsor's protocol ID: R.21.10.1492
Status last verified: Jan 2023
First submitted: 1 Jan 2023
Last updated: 4 Jan 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Diabetic Foot Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Novel Bioactive Smart Dressings for Diabetic Foot Ulcers: a Randomized Controlled Trial Comparing Efficacy of PRP-loaded Lyophilized Gel vs. Erythropoietin/Isosorbide Dinitrate Cryogel Scaffold vs. Standard of Care
ClinicalTrials.gov ID: NCT05671250
Acronym / sponsor ID: R.21.10.1492
Conditions: Diabetic Foot Ulcer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Mansoura UniversityUniversity, hospital or other
Study start: 15 Jul 2021 (actual)
Primary completion: 1 Nov 2022 (actual)
Study completion: 1 Jan 2023 (actual)
First posted: 4 Jan 2023 (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.

We propose a randomized controlled study to assess the efficacy of:

Platelet-lysate loaded sustained release thermo-gelling formulation (Platelets-SR)
EPO/ISDN/UFH cryogel dressing (Trigel) As adjuncts to standard-of-care (SOC) in the treatment of chronic DFUs compared to SOC alone for patients attending the DFU outpatient clinic at the Gastroenterology Centre, Mansoura University.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
PRP gel and SOC-treatment	Experimental	Combination Product: PRP gel and SOC-treatmentplatelet-lysate loaded lyophilized gel in addition to standard of care
Trigel and SOC-treatment	Experimental	Combination Product: EPO/ISDN/UFH cryogel dressingErythropoietin/isosorbide dinitrate loaded cryogel scaffold in addition to standard of care
standard of care alone	Active comparator	Procedure: Standard of Caresharp debridement, saline washing and saline dressing

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Male or female age of ≥ 18
Type 2 Diabetes Mellitus diagnosed as per the American Diabetic Association at the time of recruitment
Patients with glycated haemoglobin (HbA1C) ≤ 9% within 4 weeks prior to randomization
Patients with ulcer that meets the following criteria
Limb criteria: At least moderate blood perfusion into the affected limb as defined by Ankle Brachial Index (ABI) of 0.9 - 1.3.

Key exclusion criteria (14 listed)

Type 1 Diabetes Mellitus
Patients who have undergone, in the 2-week period prior to enrolment, treatment for DFU with any advanced treatment modality other than standard of care, such as growth factors, skin substitutes or other biological treatments
Have a glycosylated haemoglobin (HbA1c) > 9.0%
Have a body mass index (BMI) > 40 Kg/m2
Have a clinically significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease

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 gel and SOC-treatmentPlatelet-lysate loaded sustained release thermo-gelling formulation	Combination product	PRP gel and SOC-treatment
EPO/ISDN/UFH cryogel dressingErythropoietin/Isosorbide dinitrate loaded cryogel scaffold	Combination product	Trigel and SOC-treatment
Standard of CareSharp debridement, saline washing and regular saline dressing	Procedure or surgery	standard of care alone

Primary outcome

Wound area regression rate
Time frame: 8 weeks
wound area regression rate assessed weekly (cm2/week)

3 secondary outcomes

rate of complete wound closure
Time frame: 8 weeks
rate of partial wound closure of ≥ 75%
Time frame: 8 weeks
rate of partial wound closure of ≥ 50%
Time frame: 8 weeks

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 4 Jan 2023.
Individual participant dataSharing planned: No

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.

Toaa Ashraf study director

Mansoura University

Amira Motawea study director

Mansoura University

Marwa S. El-Dahhan study director

Mansoura University

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 PRP gel and SOC-treatment and EPO/ISDN/UFH cryogel dressing in people with Diabetic Foot Ulcer, run by Mansoura 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 13 inclusion and 14 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 4 Jan 2023. 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. 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?

Wound area regression rate (time frame: 8 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 NCT05671250.

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 4 Jan 2023.