A Prospective, Open-Label, Randomized, Comparative, Investigator-Initiated Study to Evaluate the Safety and...

Background and objectives The persistent nature of diabetic foot ulcers (DFUs) is mainly attributable to compromised wound healing mechanisms, which are aggravated due to poor blood flow, neuropathy, and infection. Growth factors have become essential agents in the treatment of DFUs, serving as primary mediators that enhance wound healing through the stimulation of cell proliferation, migration, and angiogenesis. This prospective open-label, randomised, comparative, multi-centre, investigator-initiated study compared the safety and effectiveness of adjuvant therapy with topical application of autologous growth factor concentrate (AGFC) using the Healrex^® therapy kit (Wockhardt, India) versus standard of care (SoC) in DFUs. Methods Fifty-two adult men and women with DFU (Grades I or II as per Maggitt-Wagner classification) were randomised to the Healrex^® (n = 26) or SoC (n = 26) group. AGFC concentrate was prepared using the Healrex^® therapy kit, and application was from baseline to day 70 (visit 2 to visit 16). Wound assessment and size estimation post debridement were done from screening, i.e., day -03 to -01 day to 70 days (visit 1 to visit 16). The primary outcome was complete response defined as the proportion of patients having healthy granulation tissue covering ≥75% of the ulcer surface at the test of cure (ToC) or visit 17, whereas secondary outcomes were the percentage of patients with complete wound closure at ToC/visit 17, mean percentage reduction of ulcer size at ToC/visit 17 and time to appearance of healthy granulation tissues. Safety was measured in the form of treatment-emergent adverse events (TEAEs) reported, deviations in the desirable range of parameters determined using laboratory tests (haematology, serum biochemistry, urine examination), and electrocardiogram (ECG) done from baseline to ToC. Two patients were lost to follow-up, and one from the Healrex^® arm was withdrawn from the study, resulting in a final efficacy analysis on 49 participants (24 in the Healrex^® group and 25 in the SoC group) in the per-protocol (PP) dataset. Safety analysis was conducted on the intention-to-treat (ITT) dataset, which included all 52 participants. Results Complete response was observed in all 24 patients (n = 24 (100.0%)) with Healrex^® compared to only n = 21 (84.0%) with SoC (p = 0.042). Complete wound closure was observed in 11 patients (n = 24 (45.8%)) treated with Healrex^® compared to 13 patients (n = 13 (52.0%)) with SoC. The time required for wound closure was similar (p = 0.669) in the two groups. A greater reduction in the ulcer area was observed with Healrex^® as against SoC (p < 0.0001). The time for the emergence of healthy granulation tissue was comparable between the two groups (p = 0.342). Ten patients with Healrex^® reported mild adverse events (headache, fever, and cold) and none with SoC. Conclusion AGFC application using the Healrex^® therapy kit as an adjuvant to standard wound care provides better outcomes compared to SoC alone in the management of DFUs.