Bioactive Smart Dressings for Diabetic Foot Ulcers: Randomized Controlled Trial

NCT ID: NCT05671250

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2023-01-01

Brief 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 outpatient clinic at the Gastroenterology Centre, Mansoura University.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PRP gel and SOC-treatment

platelet-lysate loaded lyophilized gel in addition to standard of care

Group Type: EXPERIMENTAL

PRP gel and SOC-treatment

Intervention Type: COMBINATION_PRODUCT

Platelet-lysate loaded sustained release thermo-gelling formulation

Trigel and SOC-treatment

Erythropoietin/isosorbide dinitrate loaded cryogel scaffold in addition to standard of care

Group Type: EXPERIMENTAL

EPO/ISDN/UFH cryogel dressing

Intervention Type: COMBINATION_PRODUCT

Erythropoietin/Isosorbide dinitrate loaded cryogel scaffold

standard of care alone

sharp debridement, saline washing and saline dressing

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: PROCEDURE

Sharp debridement, saline washing and regular saline dressing

Interventions

PRP gel and SOC-treatment

Platelet-lysate loaded sustained release thermo-gelling formulation

Intervention Type: COMBINATION_PRODUCT

EPO/ISDN/UFH cryogel dressing

Erythropoietin/Isosorbide dinitrate loaded cryogel scaffold

Intervention Type: COMBINATION_PRODUCT

Standard of Care

Sharp debridement, saline washing and regular saline dressing

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Male or female age of ≥ 18

2. Type 2 Diabetes Mellitus diagnosed as per the American Diabetic Association at the time of recruitment

3. Patients with glycated haemoglobin (HbA1C) ≤ 9% within 4 weeks prior to randomization

4. Patients with ulcer that meets the following criteria

1. 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)

2. Ulcer duration of 4 weeks or longer and hard to heal despite standard of care treatment (chronic ulcers)

3. Ulcer has undergone recent debridement (2 weeks prior to screening)

4. Post-debridement ulcer is free of necrotic debris, foreign bodies, sinus tracts, tunnelling, and undermining and is comprised of healthy vascularized tissue

5. Wound area at start of treatment between 2 sq.cm. and 10 sq.cm.

6. No surgical revascularization of the limb with the DFU was done in the previous two months.

5. Limb criteria: At least moderate blood perfusion into the affected limb as defined by Ankle Brachial Index (ABI) of 0.9 - 1.3.

6. Patients who agree to conform to the off-loading requirements

7. Provide written informed consent prior to admission into the study

Exclusion Criteria

1. Type 1 Diabetes Mellitus

2. 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

3. Have a glycosylated haemoglobin (HbA1c) > 9.0%

4. Have a body mass index (BMI) > 40 Kg/m2

5. Have a clinically significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease

6. 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

7. Patients with haemochromatosis or unstable hypertension

8. 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

9. Patients with wounds caused by basal cell carcinoma or due to basal cell carcinoma excision

10. 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.

11. Patients with a history of allergy to one of tested components

12. Patients on glyceryl trinitrate or Sildenafil treatment

13. 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

14. Patients with active Charcot or other structural deformity that would prevent adequate off-loading of the study foot.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Toaa Ashraf

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Toaa Ashraf

Role: STUDY_DIRECTOR

Mansoura University

Amira Motawea

Role: STUDY_DIRECTOR

Mansoura University

Marwa S. El-Dahhan

Role: STUDY_DIRECTOR

Mansoura University

Fady Azmy

Role: STUDY_DIRECTOR

Mansoura University

Galal M. Abdelghani

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

Toaa Ashraf

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

R.21.10.1492

Identifier Type: -

Identifier Source: org_study_id