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Heberprot-P for Diabetic Foot Ulcers: What the Evidence Shows

A measured review of intralesional recombinant human EGF, its place alongside standard wound care, and the records a specialist needs before discussing suitability.

Medical disclaimer: This page is for information and international coordination only. It does not diagnose, prescribe, guarantee suitability or replace urgent local medical care.
Evidence at a glance

What the current research shows.

Published randomized studies and a later meta-analysis suggest that intralesional recombinant human EGF may improve granulation and wound closure when added to standard care. The trials are relatively small and do not justify a guaranteed claim about healing or amputation avoidance. Infection control, vascular assessment, offloading, debridement and diabetes management remain essential.

What it is

A Cuban-developed therapy used alongside standard wound care.

Heberprot-P is a recombinant human epidermal growth factor developed and manufactured in Cuba, where it has been registered and used in clinical practice for complex diabetic foot ulcers for more than a decade. It is administered by injection into and around the wound bed, in a clinical setting, at intervals set by the treating physician, and the wound continues to be measured, photographed and monitored throughout the course. It is designed to work together with standard wound care — debridement, infection control, offloading and vascular management — rather than instead of any of them. International patients typically learn whether it is even a relevant topic for their specific case through medical coordination, only after a documented wound history has been organized and reviewed by a physician, and only alongside the rest of the wound-care plan already in place.

01

Recombinant human epidermal growth factor

The active substance is a laboratory-produced growth factor intended to support the body's own tissue-repair process at the wound site. It is not an antibiotic, a dressing or a skin graft, and it does not replace any step a wound-care team already uses to manage a complex ulcer. Growth-factor approaches are one category among several used in advanced wound care; Heberprot-P is Cuba's specific, registered version of that approach.

02

Developed and registered in Cuba

Heberprot-P was developed by Cuban biotechnology researchers and has been used in Cuban clinical practice for advanced diabetic foot ulcers for a number of years, with clinical literature published around its use. It is registered and administered inside Cuba, by Cuban wound-care physicians, which is where the coordination process for international patients ultimately leads if a case reaches that stage.

03

An adjunct, not a replacement

It is intended to accompany debridement, infection control, vascular management and diabetes management, not to substitute for any of them. Standard wound care continues throughout any course of treatment, and none of these underlying steps — cleaning the wound, treating infection, protecting circulation, managing blood sugar — are skipped because Heberprot-P has entered the conversation.

04

How it is administered

The therapy is injected into and around the ulcer bed by trained clinical staff, typically across a defined treatment course set by the physician rather than by the patient. The wound is measured, photographed and monitored throughout, so the treating team can see whether it is responding as expected and adjust the broader wound-care plan if it is not.

05

The intended clinical role

In select, physician-reviewed cases, it may be discussed as part of a broader limb-preservation strategy aimed at supporting granulation tissue and helping avoid amputation. It is never presented as a guaranteed outcome for any individual patient, and it is only ever considered after the wound, the circulation and the infection status have been fully documented.

06

Why the file comes first

Before Heberprot-P is even a relevant topic, a physician needs a clear picture of the wound, the circulation and the infection status. That review is the actual starting point, not the treatment itself, and if the file is incomplete, the physician's response will usually explain what is missing rather than offer a final answer.

Heberprot-P for Diabetic Foot Ulcers: What the Evidence Shows
Wound careHeberprot-P for Diabetic Foot Ulcers: What the Evidence Shows

A measured review of intralesional recombinant human EGF, its place alongside standard wound care, and the records a specialist needs before discussing suitability.

Candidacy review

What a physician needs to see before Heberprot-P is even discussed.

Candidacy is not decided from a single photo or a short message, and it is not decided quickly. It is decided from a documented file that lets a physician understand the wound itself, the circulation, the infection status and the patient's overall diabetes control, along with what has already been tried. Because the file has to travel and be reviewed remotely, organization matters as much as content. The list below is what a coordination team typically helps a patient assemble before any specialist looks at the case.

01

Wound classification and history

Grade, depth, size, duration and how the ulcer has changed over time are documented, ideally supported by a dated sequence of clear photographs taken under consistent lighting, with a ruler or similar scale reference, so genuine change is visible from one visit to the next.

02

Vascular status and circulation

Doppler results, ABI measurements, angiography findings or any prior vascular surgery are reviewed, because blood supply to the limb affects what treatment is realistic or safe to consider. A physician needs this information before discussing any advanced wound therapy, not after.

03

Infection status

Culture results, current antibiotics, inflammatory markers, imaging for bone infection and any recent hospitalization are reviewed, since active infection is usually addressed before anything else is considered. An infected or unstable wound changes the immediate priority, sometimes ahead of any coordination discussion at all.

04

Diabetes and systemic control

HbA1c, current glucose management, kidney function and nutrition status are part of the file, since healing capacity is closely tied to how well diabetes and related systemic factors are controlled overall, not to the wound in isolation.

05

Previous wound-care history

Dressings, offloading, debridement, negative-pressure therapy and any prior therapies already tried are summarized in chronological order, along with how the wound responded to each one. This history helps the physician avoid repeating something that has already failed to work.

06

A physician's individual decision

Every file is reviewed case by case, on its own facts, by a licensed physician. Candidacy is never assumed in advance, and not every patient who asks about Heberprot-P will ultimately be considered a candidate for it, regardless of how the initial inquiry is worded.

Before you start

What this article is not saying.

Heberprot-P is discussed here as a physician-review topic, not as a guaranteed outcome or a solution for every diabetic foot ulcer. A few points are worth stating plainly before anyone starts an application or begins gathering records, so expectations stay realistic from the first step onward rather than after a file has already been submitted.

01

Individual results vary

How any wound responds depends on circulation, infection control, diabetes management and the condition of the wound itself, and these factors differ from one patient to the next. No outcome can be promised in advance, and this article does not attempt to estimate one, quote a success rate or suggest a typical healing time. Another patient's experience is not a forecast for a new case.

02

Some patients are not candidates

Critical limb ischemia or uncontrolled infection usually needs urgent local care first — emergency, vascular or infectious-disease specialists, not an international coordination request. In these situations, waiting on a file review is not the appropriate next step, and local emergency or specialist treatment should never be delayed for it.

03

The decision belongs to a physician

Cuba Health Assist coordinates the file, the communication and the logistics around a case, but it does not make medical decisions and does not treat patients directly. Suitability, dosing and monitoring are determined only by the licensed physicians who review the file, and only after they have seen the complete picture.

Mechanism and administration

What Heberprot-P is and how it is given

Heberprot-P contains recombinant human epidermal growth factor (rhEGF). Epidermal growth factor is a signalling protein the body normally uses in tissue repair: it stimulates cell proliferation, new vessel formation and the development of granulation tissue. In chronic diabetic foot ulcers this natural repair signal is insufficient, which is why a wound can remain open for months. The aim of treatment is to deliver the growth factor directly into the wound bed and restart a process that has stalled.

It is not a cream or a dressing. Treatment is given as intralesional injections into the base and edges of the wound, typically three times a week, under sterile conditions and by trained staff. Duration depends on response; published protocols stop when granulation tissue covers roughly 50 to 75 per cent of the wound surface, and in most patients total treatment does not exceed eight weeks.

Wound preparation beforehand is mandatory: removal of dead tissue (debridement), treatment of any infection, investigation for osteomyelitis, and assessment of circulation in the leg. In a foot with critically impaired blood flow, no wound treatment delivers the expected result until the vessels are addressed, so vascular assessment usually comes first.

The most frequently reported side effects are pain and burning at the injection site, shivering, fever, nausea and dizziness; these are usually transient and managed during administration. Throughout treatment, glycaemic control, offloading the wound with suitable footwear or a cast, and regular dressing changes remain equally important. Heberprot-P is added to that basic care, not substituted for it.

Eligibility and limits

When is treatment deferred or considered unsuitable?

The situations below rarely mean a definitive no; most are problems to solve first. The decision always belongs to the treating physician.

01

Uncontrolled infection

Spreading soft-tissue infection, abscess or suspected bone infection (osteomyelitis) must be treated first. Application during active infection does not change the outcome, it only delays it.

02

Critical limb ischaemia

Where pulses are absent and there is rest pain or tissue loss, restoring blood flow takes priority. Granulation tissue will not form without adequate perfusion.

03

Suspicion of malignancy

Unusual-looking wounds, raised edges or wounds that never respond may require biopsy. Growth factor should not be applied before malignancy has been excluded.

04

Poor metabolic state

Very high or unstable blood glucose, advanced kidney failure, malnutrition or active heart failure directly impair healing; response remains limited until these are corrected.

Frequently asked questions

Common questions about Heberprot-P

Does Heberprot-P heal the wound on its own?

No. Every published study examines it as an addition to standard wound care. Without debridement, infection control, vascular assessment, offloading and glycaemic management in place, growth factor alone will not deliver the expected benefit.

How long does treatment take?

Protocols generally schedule three applications per week. Duration follows the response and in many patients ranges from a few weeks up to eight. The number of applications cannot be guaranteed in advance, because the decision is reviewed at each assessment of the granulation tissue.

Is it painful, and what are the side effects?

Pain and burning at the injection site are the most commonly reported effects. Shivering, fever, nausea and dizziness can also occur; these are usually transient and managed in a clinical setting. Side effects may require the schedule to be reduced or stopped.

Is this medicine licensed everywhere?

No. Heberprot-P was developed in Cuba and is licensed in a number of countries; it is not approved for routine use in the European Union or the United States. Treatment is therefore arranged where the product is licensed and where administration can take place in an authorised facility.

Does it definitely prevent amputation?

No, and no such guarantee can be given. Studies report positive signals for granulation and wound closure, but their size and design do not support a firm promise about avoiding amputation. Circulation, infection control and offloading remain the strongest determinants of outcome.

Start with the file

Start the review with your medical file.

Send your documents through the secure application area. The coordination team will help organize the file and outline next steps.